Back to resultsSPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Primary Purpose
Endometriosis Related Pain
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Relugolix
Estradiol/norethindrone acetate
Estradiol/norethindrone acetate placebo
Relugolix placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis Related Pain focused on measuring Endometriosis, Pain, Dysmenorrhea
Eligibility Criteria
Key Inclusion Criteria:
- Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
- Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
- Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy.
During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea NRS score ≥ 4.0 on at least 2 days and
- Mean NMPP NRS score ≥ 2.5, or
- Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days.
Key Exclusion Criteria:
- Has a history of chronic pelvic pain that is not caused by endometriosis.
- 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 had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit.
- Has a history of or currently has osteoporosis or other metabolic bone disease.
- Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy.
Sites / Locations
- Andalusia
- Washington DC
- Aventura
- Deland
- Hialeah
- Hialeah
- Margate
- Miami
- Port St. Lucie
- Tampa
- Atlanta
- Idaho Falls
- Park Ridge
- Lafayette
- Covington
- Marrero
- Towson
- Saginaw
- St. Louis
- Omaha
- Albuquerque
- New York
- New Bern
- Akron
- Columbus
- Columbus
- Franklin
- Columbia
- Spartanburg
- Chattanooga
- Beaumont
- Corpus Christi
- Dallas
- Fort Worth
- Houston
- Irving
- San Antonio
- Sugar Land
- Pleasant Grove
- Salt Lake City
- Virginia Beach
- Sydney
- Wollongong
- Sherwood
- Adelaide
- Nedlands
- Passo Fundo
- Porto Alegre
- Porto Alegre
- Porto Alegre
- Porto Alegre
- São Bernardo do Campo
- São Paulo
- São Paulo
- São Paulo
- São Paulo
- São Paulo
- Santiago
- Santiago
- Santiago
- Santiago
- Písek
- Tábor
- Praha 2
- Ceské Budejovice
- Tbilisi
- Monserrato
- Catanzaro
- Napoli
- Pavia
- Roma
- Birkenhead
- Remuera
- Tauranga
- Palmerston North
- Christchurch
- Lodz
- Lublin
- Lublin
- Warszawa
- Warszawa
- Warszawa
- Bialystok
- Białystok
- Katowice
- Poznan
- București
- Brasov
- Bucuresti
- Bucuresti
- Malmö
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Relugolix plus E2/NETA (Group A)
Relugolix plus Delayed E2/NETA (Group B)
Placebo (Group C)
Arm Description
Relugolix co-administered with E2/NETA for 24 weeks.
Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Outcomes
Primary Outcome Measures
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT)
Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary (e-Diary). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage Of Participants Who Meet The Non-Menstrual Pelvic Pain (NMPP) Responder Criteria At Week 24 Or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Secondary Outcome Measures
Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24
Assessed using the Pain Domain of the EHP-30 questionnaire.
Change From Baseline In Dysmenorrhea NRS Score At Week 24 Or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change From Baseline In NMPP NRS Score At Week 24 Or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change From Baseline In Overall Pelvic Pain NRS Score At Week 24 Or EOT
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change From Baseline In Dyspareunia NRS Scores At Week 24 Or EOT
Assessed using an NRS score (11-point scale) for dyspareunia recorded daily in an e-Diary.
Percentage Of Participants Who Are Not Using Opioids For Endometriosis-associated Pain At Week 24 Or EOT
Assessed based on usage of protocol-specified opioids for endometriosis-associated pain recorded daily in an e-Diary.
Change From Baseline In Analgesic Use For Endometriosis-associated Pain Based On Mean Pill Count At Week 24 Or EOT
Assessed based on usage of protocol-specified analgesic for endometriosis-associated pain recorded daily in an e-Diary.
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24
Assessed using the pain domain of the EHP-30 questionnaire.
Dysmenorrhea Responder Rate By Month
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
NMPP Responder Rate By Month
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Change In Dysmenorrhea NRS Score By Month
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change In NMPP NRS Score By Month
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change In Overall Pelvic Pain NRS Score By Month
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change In Dyspareunia NRS Score By Month
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Change From Baseline In Ibuprofen Use At Week 24 Or EOT
Assessed using ibuprofen pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Change From Baseline In Opioid Use At Week 24 Or EOT
Assessed using opioid pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Change From Baseline In The Mean Dysmenorrhea Functional Impairment At Week 24 Or EOT
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary.
Change From Baseline In The Mean NMPP Functional Impairment At Week 24 Or EOT
Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary.
Change From Baseline In The Mean Dyspareunia Functional Impairment At Week 24 Or EOT
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary.
Change From Baseline In Patient Global Assessment (PGA) For Dysmenorrhea Symptom Severity At Week 24
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Dysmenorrhea At Week 24
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Change From Baseline In PGA For NMPP Symptom Severity At Week 24
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For NMPP At Week 24
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Change From Baseline In PGA For Pain Severity At Week 24
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Pain Severity At Week 24
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Change From Baseline In PGA For Function At Week 24
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Function At Week 24
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 24
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 24
The PGIC for NMPP is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 24
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during sexual intercourse.
Change From Baseline In The Non-Pain Of The EHP-30 Domains At Week 24
Assessed using the non-pain domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image) of the EHP-30 questionnaire.
Change From Baseline In The EHP-30 Scale Total Score At Week 24
Assessed using the total score of the EHP-30 questionnaire.
Change From Baseline In The EHP Work Domain Score At Week 24
The EHP Work domain is a 5-item questionnaire that assesses impact of pain on ability to work.
Categorical Change From Baseline In Quality Of Life Assessed By European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Questionnaire At Week 24
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Change From Baseline To Week 24 In EQ-5D-5L Visual Analogue Scale Score At Week 24
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Change From Baseline In The EHP-30 Pain Score At Week 24 For Relugolix Plus Delayed E2/NETA
Assessed using the Pain Domain of the EHP-30 questionnaire.
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24 For Relugolix Plus Delayed E2/NETA
Assessed using the pain domain of the EHP-30 questionnaire.
Percentage Change From Baseline In Bone Mineral Density At The Lumbar Spine (L1-L4) At Week 12
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percentage Change From Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 24
Assessed by DXA scan.
Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B
Change From Baseline In Serum Concentrations Of Luteinizing Hormone, Follicle Stimulating Hormone, Estradiol, And Progesterone
Blood samples will be collected from participants for hormonal measurements.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03204331
Brief Title
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Official Title
SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 31, 2021 (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 determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
Detailed Description
This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered with either 12 or 24 weeks of low-dose E2 (1.0 mg) and NETA (0.5 mg), compared with placebo.
Approximately 600 women with endometriosis-associated pain were enrolled and randomized 1:1:1 to Group A - relugolix plus low-dose hormonal add-back therapy, Group B - relugolix monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back therapy, or Group C - placebo (N = 200 per group).
Eligible participants were randomized on Baseline Day 1 to Treatment Group A, B, or C, in the double-blind period.
Eligible participants, including those randomized to placebo, were offered the opportunity to enroll in an 80-week open label extension study where participants received relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a Follow-Up visit approximately 30 days after the participant's last dose of study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Related Pain
Keywords
Endometriosis, Pain, Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
623 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relugolix plus E2/NETA (Group A)
Arm Type
Experimental
Arm Description
Relugolix co-administered with E2/NETA for 24 weeks.
Arm Title
Relugolix plus Delayed E2/NETA (Group B)
Arm Type
Experimental
Arm Description
Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Arm Title
Placebo (Group C)
Arm Type
Placebo Comparator
Arm Description
Relugolix placebo co-administered with E2/NETA placebo for 24 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
Intervention Description
Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Estradiol/norethindrone acetate placebo
Intervention Description
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
Intervention Type
Drug
Intervention Name(s)
Relugolix placebo
Intervention Description
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Primary Outcome Measure Information:
Title
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT)
Description
Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary (e-Diary). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
Week 24 or EOT
Title
Percentage Of Participants Who Meet The Non-Menstrual Pelvic Pain (NMPP) Responder Criteria At Week 24 Or EOT
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
Week 24 or EOT
Secondary Outcome Measure Information:
Title
Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24
Description
Assessed using the Pain Domain of the EHP-30 questionnaire.
Time Frame
Baseline, Week 24
Title
Change From Baseline In Dysmenorrhea NRS Score At Week 24 Or EOT
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Change From Baseline In NMPP NRS Score At Week 24 Or EOT
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Change From Baseline In Overall Pelvic Pain NRS Score At Week 24 Or EOT
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Change From Baseline In Dyspareunia NRS Scores At Week 24 Or EOT
Description
Assessed using an NRS score (11-point scale) for dyspareunia recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Percentage Of Participants Who Are Not Using Opioids For Endometriosis-associated Pain At Week 24 Or EOT
Description
Assessed based on usage of protocol-specified opioids for endometriosis-associated pain recorded daily in an e-Diary.
Time Frame
Week 24 or EOT
Title
Change From Baseline In Analgesic Use For Endometriosis-associated Pain Based On Mean Pill Count At Week 24 Or EOT
Description
Assessed based on usage of protocol-specified analgesic for endometriosis-associated pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24
Description
Assessed using the pain domain of the EHP-30 questionnaire.
Time Frame
Baseline to Week 24
Title
Dysmenorrhea Responder Rate By Month
Description
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
Baseline to Week 24
Title
NMPP Responder Rate By Month
Description
The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
Baseline to Week 24
Title
Change In Dysmenorrhea NRS Score By Month
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline to Week 24
Title
Change In NMPP NRS Score By Month
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline to Week 24
Title
Change In Overall Pelvic Pain NRS Score By Month
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline to Week 24
Title
Change In Dyspareunia NRS Score By Month
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary.
Time Frame
Baseline to Week 24
Title
Change From Baseline In Ibuprofen Use At Week 24 Or EOT
Description
Assessed using ibuprofen pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24
Title
Change From Baseline In Opioid Use At Week 24 Or EOT
Description
Assessed using opioid pill counts for endometriosis-associated pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24
Title
Change From Baseline In The Mean Dysmenorrhea Functional Impairment At Week 24 Or EOT
Description
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Change From Baseline In The Mean NMPP Functional Impairment At Week 24 Or EOT
Description
Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Change From Baseline In The Mean Dyspareunia Functional Impairment At Week 24 Or EOT
Description
Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary.
Time Frame
Baseline, Week 24 or EOT
Title
Change From Baseline In Patient Global Assessment (PGA) For Dysmenorrhea Symptom Severity At Week 24
Description
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Dysmenorrhea At Week 24
Description
The PGA for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of the severity of pain during their menstrual cycle.
Time Frame
Week 24
Title
Change From Baseline In PGA For NMPP Symptom Severity At Week 24
Description
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For NMPP At Week 24
Description
The PGA for NMPP is a 1-item questionnaire designed to assess participants' impression of the severity of pain when they are not menstruating.
Time Frame
Week 24
Title
Change From Baseline In PGA For Pain Severity At Week 24
Description
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Pain Severity At Week 24
Description
The PGA for pain severity is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Time Frame
Week 24
Title
Change From Baseline In PGA For Function At Week 24
Description
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants With Improvement, No Change, Or Worsening From Baseline In PGA For Function At Week 24
Description
The PGA for function is a 1-item questionnaire designed to assess participants' impression of how their pain affected their usual activities.
Time Frame
Week 24
Title
Percentage Of Participants Who Are "Better" Or "Much Better" On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 24
Description
The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
Time Frame
Week 24
Title
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For NMPP At Week 24
Description
The PGIC for NMPP is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during their menstrual cycle.
Time Frame
Week 24
Title
Percentage Of Participants Who Are "Better" Or "Much Better" On The PGIC For Dyspareunia At Week 24
Description
The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants' impression of change in the severity of pain during sexual intercourse.
Time Frame
Week 24
Title
Change From Baseline In The Non-Pain Of The EHP-30 Domains At Week 24
Description
Assessed using the non-pain domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image) of the EHP-30 questionnaire.
Time Frame
Baseline, Week 24
Title
Change From Baseline In The EHP-30 Scale Total Score At Week 24
Description
Assessed using the total score of the EHP-30 questionnaire.
Time Frame
Baseline, Week 24
Title
Change From Baseline In The EHP Work Domain Score At Week 24
Description
The EHP Work domain is a 5-item questionnaire that assesses impact of pain on ability to work.
Time Frame
Baseline, Week 24
Title
Categorical Change From Baseline In Quality Of Life Assessed By European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Questionnaire At Week 24
Description
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Time Frame
Baseline, Week 24
Title
Change From Baseline To Week 24 In EQ-5D-5L Visual Analogue Scale Score At Week 24
Description
The EQ-5D-5L is a 5-item questionnaire designed to assess quality of life.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
Week 24 or EOT
Title
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 24 Or EOT For Relugolix Plus Delayed E2/NETA
Description
Assessed using an NRS score (11-point scale) for pain recorded daily in an e-Diary. The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame
Week 24 or EOT
Title
Change From Baseline In The EHP-30 Pain Score At Week 24 For Relugolix Plus Delayed E2/NETA
Description
Assessed using the Pain Domain of the EHP-30 questionnaire.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants Who Have A Reduction Of At Least 20 Points In The EHP-30 Pain Domain From Baseline To Week 24 For Relugolix Plus Delayed E2/NETA
Description
Assessed using the pain domain of the EHP-30 questionnaire.
Time Frame
Baseline to Week 24
Title
Percentage Change From Baseline In Bone Mineral Density At The Lumbar Spine (L1-L4) At Week 12
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Baseline, Week 12
Title
Percentage Change From Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 24
Description
Assessed by DXA scan.
Time Frame
Baseline, Week 24
Title
Percentage Of Participants Experiencing Vasomotor Symptoms At Week 12 Between Group A And B
Time Frame
Week 12
Title
Change From Baseline In Serum Concentrations Of Luteinizing Hormone, Follicle Stimulating Hormone, Estradiol, And Progesterone
Description
Blood samples will be collected from participants for hormonal measurements.
Time Frame
Baseline, Week 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy.
During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea NRS score ≥ 4.0 on at least 2 days and
Mean NMPP NRS score ≥ 2.5, or
Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days.
Key Exclusion Criteria:
Has a history of chronic pelvic pain that is not caused by endometriosis.
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 had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit.
Has a history of or currently has osteoporosis or other metabolic bone disease.
Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy.
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
Washington DC
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
Deland
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
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
33176
Country
United States
Facility Name
Port St. Lucie
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
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
Idaho Falls
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Park Ridge
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Lafayette
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
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
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
68124
Country
United States
Facility Name
Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
New Bern
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
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
43231
Country
United States
Facility Name
Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Franklin
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Columbia
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
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
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
Pleasant Grove
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Virginia Beach
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Wollongong
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2522
Country
Australia
Facility Name
Sherwood
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
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
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
01317-000
Country
Brazil
Facility Name
São Paulo
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
01323-900
Country
Brazil
Facility Name
São Paulo
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
São 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
Santiago
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Santiago
City
Santiago
ZIP/Postal Code
8320165
Country
Chile
Facility Name
Santiago
City
Santiago
ZIP/Postal Code
8360160
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
39701
Country
Czechia
Facility Name
Tábor
City
Tábor
State/Province
Jihormoravsky KRAJ
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Praha 2
City
Praha 2
State/Province
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Ceské Budejovice
City
České Budějovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Tbilisi
City
Tbilisi
State/Province
Borjomi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Monserrato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
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
Birkenhead
City
Birkenhead
State/Province
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Remuera
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1050
Country
New Zealand
Facility Name
Tauranga
City
Tauranga
State/Province
Bay Of Plenty
ZIP/Postal Code
3112
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
Lodz
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
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
Bialystok
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-224
Country
Poland
Facility Name
Białystok
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-464
Country
Poland
Facility Name
Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-301
Country
Poland
Facility Name
Poznan
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
Country
Poland
Facility Name
București
City
București
State/Province
Bucuresti
ZIP/Postal Code
20475
Country
Romania
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
Malmö
City
Malmö
State/Province
Skane
ZIP/Postal Code
20502
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35717987
Citation
Giudice LC, As-Sanie S, Arjona Ferreira JC, Becker CM, Abrao MS, Lessey BA, Brown E, Dynowski K, Wilk K, Li Y, Mathur V, Warsi QA, Wagman RB, Johnson NP. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2). Lancet. 2022 Jun 18;399(10343):2267-2279. doi: 10.1016/S0140-6736(22)00622-5. Erratum In: Lancet. 2022 Aug 27;400(10353):660.
Results Reference
derived
Learn more about this trial
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
We'll reach out to this number within 24 hrs