Back to resultsSPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Relugolix
Estradiol/norethindrone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Dysmenorrhea, Pain, Dyspareunia, Pelvic Pain
Eligibility Criteria
Key Inclusion Criteria:
- Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
- Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
- Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
Key Exclusion Criteria:
- Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
- Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for ≥ 7 days per month.
- Has a Z-score < -2.0 or has a ≥ 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density.
Has any contraindication to treatment with low-dose E2 and NETA, including:
- Known, suspected, or history of breast cancer;
- Known or suspected estrogen-dependent neoplasia;
- Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
- History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
- Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA;
- Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden;
- Migraine with aura;
- History of porphyria.
Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102):
- Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN); or
- Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
Sites / Locations
- Andalusia
- Scottsdale
- Tucson
- Tuscon
- Canoga Park
- Los Angeles
- San Diego
- Greenwood Village
- Washington
- Aventura
- Fort Myers
- Hialeah
- Hialeah
- Margate
- Miami
- Miami
- Sarasota
- Tampa
- Atlanta
- Atlanta
- Augusta
- Norcross
- Idaho Falls
- Oakbrook
- Park Ridge
- Shawnee
- Marrero
- Towson
- Saginaw
- Jefferson City
- St. Louis
- Omaha
- Las Vegas
- Durham
- New Bern
- Winston Salem
- Akron
- Columbus
- Englewood
- Hershey
- Columbia
- Chattanooga
- Memphis
- Beaumont
- Corpus Christi
- Dallas
- Fort Worth
- Houston
- Houston
- Irving
- San Antonio
- Sugar Land
- Webster
- Salt Lake City
- Salt Lake City
- Salt Lake City
- Norfolk
- Richmond
- Virginia Beach
- Seattle
- Ciudad de Buenos Aires
- San Isidro
- Rosario
- Cordoba
- Sydney
- Wollongong
- Taringa
- Adelaide
- Nedlands
- Leuven
- La Louvière
- Gent
- Brussels
- Passo Fundo
- Porto Alegre
- Porto Alegre
- Porto Alegre
- Porto Alegre
- São Bernardo do Campo
- São Paulo
- Sao Paulo
- São Paulo
- Sao Paulo
- Sofia
- Sofia
- Sofia
- Sofia
- Blagoevgrad
- Pleven
- Stara Zagora
- Varna
- Red Deer
- Waterloo
- Victoriaville
- Santiago
- Santiago
- Santiago
- Písek
- Vodňany
- Tábor
- Náchod
- Praha 10
- Praha 2
- Olomouc
- Praha 8 - Libeň
- České Budějovice
- Kuopio
- Helsinki
- Oulu
- Tbilisi
- Kecskemét
- Pécs
- Békéscsaba
- Gyula
- Szeged
- Debrecen
- Debrecen
- Debrecen
- Nyíregyháza
- Monserrato
- Catanzaro
- Napoli
- Pavia
- Roma
- Remuera
- Palmerston North
- Christchurch
- Łódź
- Lublin
- Lublin
- Lublin
- Lublin
- Warszawa
- Warszawa
- Warszawa
- Białystok
- Katowice
- Katowice
- Skórzewo
- Szczecin
- Almada
- Coimbra
- Covilhã
- Porto
- Brasov
- Bucuresti
- Bucuresti
- Bucuresti
- București
- Port Elizabeth
- Centurion
- Roodepoort
- Durban
- Cape Town
- Madrid
- Valencia
- Kyiv
- Kyiv
- Kyiv
- Chernivtsi
- Ivano-Frankivsk
- Kharkiv
- Kiev
- Kiev
- Kyiv
- Zaporizhzhya
- Zaporizhzhya
- Zaporizhzhya
- Zaporizhzhya
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Relugolix plus E2/NETA
Arm Description
Relugolix co-administered with E2/NETA for 80 weeks.
Outcomes
Primary Outcome Measures
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Secondary Outcome Measures
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain during their menstrual cycle. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104
Assessed based on usage of study-specified opioids for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified opioids for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104
Assessed based on usage of study-specified analgesics for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified analgesics for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52
The PGIC for NMPP is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain when they are not menstruating. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participant's impression of change in the severity of their pain during sexual intercourse. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03654274
Brief Title
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Official Title
SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myovant Sciences GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
Detailed Description
This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3101 (SPIRIT 1 - NCT03204318) or MVT-601-3102 (SPIRIT 2 - NCT03204331). All participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2 (1.0 mg) and NETA (0.5 mg) for 80 weeks.
Approximately 800 women with endometriosis-associated pain will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 104 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose E2/NETA.
Baseline procedures for this extension study will be performed on the same day as the Week 24 Visit of the parent study. This visit, referred to as the "Week 24/Baseline Visit, will be defined as the date of completion of the last Week 24 procedure in the parent study. Participants will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the participant is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3103 will define enrollment into this study. Study participants will then take the open-label study treatment orally, once daily for 80 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Dysmenorrhea, Pain, Dyspareunia, Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open label extension
Masking
None (Open Label)
Allocation
N/A
Enrollment
802 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relugolix plus E2/NETA
Arm Type
Experimental
Arm Description
Relugolix co-administered with E2/NETA for 80 weeks.
Intervention Type
Drug
Intervention Name(s)
Relugolix
Other Intervention Name(s)
TAK-385, MVT-601
Intervention Description
Relugolix 40-mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Estradiol/norethindrone acetate
Other Intervention Name(s)
E2/NETA, low-dose hormonal add-back
Intervention Description
Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Primary Outcome Measure Information:
Title
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 52 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time Frame
Week 52
Title
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 52 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 52 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time Frame
Week 52
Title
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for dysmenorrhea declined from baseline to Week 104 by at least 2.8 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time Frame
Week 104
Title
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. A participant was defined as a responder if the NRS score for NMPP declined from baseline to Week 104 by at least 2.1 points without increased use of protocol-specified analgesics for pelvic pain at Week 104 relative to baseline. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Time Frame
Week 104
Secondary Outcome Measure Information:
Title
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 52
Description
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Endometriosis Health Profile (EHP)-30 Pain Domain Scores At Week 104
Description
Assessed using the pain domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain. The least squares (LS) mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 52
Description
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
Time Frame
Week 52
Title
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain Scores From The Pivotal Phase 3 Study Baseline At Week 104
Description
Assessed using the Pain Domain of the EHP-30 questionnaire. The EHP-30 questionnaire was completed on an electronic tablet (eTablet) device. Participants reported the frequency (never, rarely, sometimes, often, and always) with which they had difficulty with activities such as standing, sitting, walking, sleeping, and performing jobs around the house because of pain. The Pain Domain normalized scores ranged from 0 to 100, with higher scores denoting greater functional impact of pain.
Time Frame
Week 104
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 52
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Dysmenorrhea NRS Score At Week 104
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52
Description
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain during their menstrual cycle. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 52
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean NMPP NRS Score At Week 104
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants rated their pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 52
Description
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Overall Pelvic Pain NRS Score At Week 104
Description
Assessed using an NRS score (11-point scale) for overall pain recorded daily in an electronic diary. Participants rated their overall pelvic pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percentage Of Participants Not Using Opioids For Endometriosis-associated Pain At Week 104
Description
Assessed based on usage of study-specified opioids for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified opioids for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
Time Frame
Week 104
Title
Percentage Of Participants Not Using Analgesics For Endometriosis-associated Pain At Week 104
Description
Assessed based on usage of study-specified analgesics for endometriosis-associated pain recorded daily in an electronic diary. Participants received protocol-specified analgesics for treatment of endometriosis-associated pain as needed for pain but not prophylactically.
Time Frame
Week 104
Title
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 52
Description
The PGIC for NMPP is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain when they are not menstruating. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 52
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia NRS Scores At Week 104
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an electronic diary. Participants were to report whether they had vaginal sexual intercourse and rated their level of pelvic pain during intercourse on a scale from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 52
Description
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participant's impression of change in the severity of their pain during sexual intercourse. The questionnaire used a 7-point response scale: much better, better, a little better, the same, a little worse, worse, or much worse.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52
Description
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In The Mean Dyspareunia Functional Impairment At Week 104
Description
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary. Participants were to report their pain during intercourse daily using the following response options: Severe (avoids intercourse because of pain), Moderate (intercourse painful to the point of causing interruption), Mild (tolerated pain), No pain (no pain during intercourse), or No intercourse (no intercourse for other reasons). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 52
Description
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In Severity Scores On The Patient Global Assessment (PGA) For Overall Pelvic Pain At Week 104
Description
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 52
Description
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
Time Frame
Week 52
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Overall Pelvic Pain At Week 104
Description
The PGA for pelvic pain severity is a 1-item questionnaire designed to assess participant's impression of the severity of their pain. The questionnaire used a 5-point response scale; each response was given a numerical score: absent (0), mild (1), moderate (2), severe (3), or very severe (4).
Time Frame
Week 104
Title
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 52
Description
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In Function Impairment On The PGA For Function At Week 104
Description
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 52
Description
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
Time Frame
Week 52
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA Score For Function At Week 104
Description
The PGA for functional impairment is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities. The participants responded to the question: "How much were your daily activities limited by endometriosis over the last 4 weeks?" using a 5-point response scale; each response was given a numerical score: not at all (0), minimally (1), moderately (2), significantly (3), or very significantly (4).
Time Frame
Week 104
Title
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 52
Description
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In Each Of The Non-Pain EHP-30 Domains At Week 104
Description
Assessed using the following non-pain domains of the EHP-30 questionnaire: Control and Powerlessness (questions 12 through 17), Emotional Well-Being (questions 18 through 23), Social Support (questions 24 through 27), and Self-Image (questions 28 through 30). The score for each domain ranged from 0 to 100. Higher scores represent a greater impact of endometriosis. The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 52
Description
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From The Pivotal Phase 3 Study Baseline In Dysmenorrhea Functional Impairment Score At Week 104
Description
Assessed using the participant-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary. Participants were to report their pain as related to functional impairment daily in an electronic diary using the following response options: Severe (in bed all day, incapacitation), Moderate (in bed part of the day, some loss of work efficiency), Mild (some loss of work efficiency), No pain (no pain associated with menstruation during past 24 hours), or did not menstruate during the past 24 hours. Participants gave a possible score of 0 (no pain) to 4 (did not menstruate). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 52
Description
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 52
Title
Change From Pivotal Phase 3 Study Baseline In NMPP Functional Impairment Score At Week 104
Description
Assessed using the participant-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary. Participants reported their pain daily in an electronic diary using the following response options: Severe (requires strong analgesics), Moderate (noticeable pelvic pain), Mild (occasional pelvic pain), or No pain (no pain during past 24 hours). Participants gave a possible score of 0 (no pain) to 3 (severe). The LS mean was presented by pivotal study treatment group and by visit.
Time Frame
Week 104
Title
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
Time Frame
Week 52
Title
Percent Change From The Pivotal Phase 3 Study Baseline In BMD At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 104
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan at lumbar spine, total hip, and femoral neck (same leg for each participant) at each designated time point. All participants who completed treatment or terminated from the study early were required to return for a 6-month post-treatment follow-up (PTFU) and a 12-month PTFU DXA scan (except if participant was beyond 14 months from last day on treatment). Participants were also to have clinical laboratory evaluations (vitamin D, thyroid stimulating hormone, parathyroid hormone, creatinine, calcium, and phosphorous) at the 6-month and 12-month PTFU only if the PTFU DXA scans showed a bone loss of ≥3% at the lumbar spine and/or total hip compared with the parent study baseline.
Time Frame
Week 104
Title
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52
Description
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
Time Frame
Week 52
Title
Change From Pivotal Phase 3 Study Baseline In Predose Serum Concentrations Of Estradiol At Week 104
Description
Blood samples were collected from participants for estradiol measurements at each specified timepoints. Estradiol concentrations were measured using an immuno-enzymatic assay based on a commercially available kit.
Time Frame
Week 104
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
Key Exclusion Criteria:
Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for ≥ 7 days per month.
Has a Z-score < -2.0 or has a ≥ 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density.
Has any contraindication to treatment with low-dose E2 and NETA, including:
Known, suspected, or history of breast cancer;
Known or suspected estrogen-dependent neoplasia;
Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA;
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden;
Migraine with aura;
History of porphyria.
Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102):
Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN); or
Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myovant Medical Monitor
Organizational Affiliation
Myovant Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Andalusia
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Tuscon
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Canoga Park
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
70433
Country
United States
Facility Name
San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Greenwood Village
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Washington
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Hialeah
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Hialeah
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Margate
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30363
Country
United States
Facility Name
Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Norcross
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Facility Name
Idaho Falls
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Oakbrook
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Park Ridge
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Shawnee
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Marrero
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Towson
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Jefferson City
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
New Bern
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
Facility Name
Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Englewood
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Hershey
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Columbia
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Beaumont
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Corpus Christi
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Irving
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Webster
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Beach
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Ciudad de Buenos Aires
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
San Isidro
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
B1642CKL
Country
Argentina
Facility Name
Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PRB
Country
Argentina
Facility Name
Cordoba
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Wollongong
City
Wollongong
State/Province
NS
ZIP/Postal Code
2522
Country
Australia
Facility Name
Taringa
City
Taringa
State/Province
Queensland
ZIP/Postal Code
4068
Country
Australia
Facility Name
Adelaide
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Nedlands
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
La Louvière
City
La Louvière
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Gent
City
Gent
State/Province
Oost-vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Brussels
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Passo Fundo
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90510-040
Country
Brazil
Facility Name
Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Porto Alegre
City
Porto Alegre
State/Province
Sao Paulo
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
São Bernardo do Campo
City
São Bernardo do Campo
State/Province
Sao Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04708-001
Country
Brazil
Facility Name
Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Sofia
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Sofia
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Sofia
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Sofia
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
Blagoevgrad
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Pleven
City
Pleven
ZIP/Postal Code
5809
Country
Bulgaria
Facility Name
Stara Zagora
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Varna
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
Facility Name
Red Deer
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J1C4
Country
Canada
Facility Name
Victoriaville
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Santiago
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Santiago
City
Santiago
ZIP/Postal Code
8320143
Country
Chile
Facility Name
Santiago
City
Santiago
ZIP/Postal Code
8880465
Country
Chile
Facility Name
Písek
City
Písek
State/Province
Jihocesky Kraj
ZIP/Postal Code
397 01
Country
Czechia
Facility Name
Vodňany
City
Vodňany
State/Province
Jihocesky
ZIP/Postal Code
389 01
Country
Czechia
Facility Name
Tábor
City
Tábor
State/Province
Jihormoravsky Kraj
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Náchod
City
Náchod
State/Province
Kralovehradecky
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Praha 10
City
Praha 10
State/Province
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Praha 2
City
Praha 2
State/Province
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Olomouc
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Praha 8 - Libeň
City
Praha 8 - Libeň
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
České Budějovice
City
České Budějovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Kuopio
City
Kuopio
State/Province
Eastern Finland
ZIP/Postal Code
70100
Country
Finland
Facility Name
Helsinki
City
Helsinki
State/Province
Southern Finland
ZIP/Postal Code
00260
Country
Finland
Facility Name
Oulu
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Tbilisi
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Kecskemét
City
Kecskemét
State/Province
Bacs-kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Pécs
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Békéscsaba
City
Békéscsaba
State/Province
Bekes
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Gyula
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szeged
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Debrecen
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4024
Country
Hungary
Facility Name
Debrecen
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Debrecen
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Nyíregyháza
City
Nyíregyháza
State/Province
Szabolcs-szatmar-bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Monserrato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
9042
Country
Italy
Facility Name
Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Roma
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Remuera
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1050
Country
New Zealand
Facility Name
Palmerston North
City
Palmerston North
State/Province
Manawatu-wanganui
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
Christchurch
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Łódź
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
90-602
Country
Poland
Facility Name
Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-632
Country
Poland
Facility Name
Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-880
Country
Poland
Facility Name
Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-066
Country
Poland
Facility Name
Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-201
Country
Poland
Facility Name
Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-929
Country
Poland
Facility Name
Białystok
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-224
Country
Poland
Facility Name
Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-301
Country
Poland
Facility Name
Skórzewo
City
Skórzewo
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Szczecin
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Almada
City
Almada
State/Province
Lisboa
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Covilhã
City
Covilhã
ZIP/Postal Code
6200-251
Country
Portugal
Facility Name
Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Brasov
City
Brasov
ZIP/Postal Code
500091
Country
Romania
Facility Name
Bucuresti
City
Bucuresti
ZIP/Postal Code
012071
Country
Romania
Facility Name
Bucuresti
City
Bucuresti
ZIP/Postal Code
022441
Country
Romania
Facility Name
Bucuresti
City
Bucuresti
ZIP/Postal Code
024091
Country
Romania
Facility Name
București
City
București
ZIP/Postal Code
20475
Country
Romania
Facility Name
Port Elizabeth
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Centurion
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Roodepoort
City
Roodepoort
State/Province
Gauteng
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Durban
City
Durban
State/Province
Kwazulu-natal
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Cape Town
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Madrid
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Kyiv
City
Kyiv
State/Province
Kiev City
ZIP/Postal Code
2232
Country
Ukraine
Facility Name
Kyiv
City
Kyiv
State/Province
Kiev City
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Kyiv
City
Kyiv
State/Province
Kiev
ZIP/Postal Code
1034
Country
Ukraine
Facility Name
Chernivtsi
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Ivano-Frankivsk
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Kharkiv
City
Kharkiv
ZIP/Postal Code
61052
Country
Ukraine
Facility Name
Kiev
City
Kiev
ZIP/Postal Code
3148
Country
Ukraine
Facility Name
Kiev
City
Kiev
ZIP/Postal Code
4112
Country
Ukraine
Facility Name
Kyiv
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Zaporizhzhya
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Zaporizhzhya
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
Zaporizhzhya
City
Zaporizhzhya
ZIP/Postal Code
69068
Country
Ukraine
Facility Name
Zaporizhzhya
City
Zaporizhzhya
ZIP/Postal Code
69071
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
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