Back to resultsSPIRIT 1: 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
- Dothan
- Mesa
- Scottsdale
- Tucson
- Tucson
- Canoga Park
- Long Beach
- San Diego
- Greenwood Village
- Fort Myers
- Loxahatchee
- Miami
- Miami
- Orlando
- Oviedo
- Plantation
- Sarasota
- Atlanta
- Augusta
- Norcross
- Idaho Falls
- Oakbrook
- Shawnee
- New Orleans
- Jefferson City
- Las Vegas
- Port Jefferson
- Durham
- Raleigh
- Winston Salem
- Englewood
- Hershey
- Philadelphia
- Memphis
- Murfreesboro
- Austin
- Houston
- Webster
- Salt Lake City
- Salt Lake City
- Norfolk
- Richmond
- Seattle
- Ciudad de Buenos Aires
- San Isidro
- Rosario
- Córdoba
- Leuven
- La Louvière
- Gent
- Brussels
- Sofia
- Sofia
- Sofia
- Blagoevgrad
- Pleven
- Sofia
- Sofia
- Stara Zagora
- Varna
- Red Deer
- Waterloo
- Victoriaville
- Praha 10
- Nachod
- Olomouc
- Praha 8 - Libeň
- Vodnany
- Vysoké Mýto
- Kuopio
- Helsinki
- Oulu
- Kecskemét
- Pécs
- Békéscsaba
- Gyula
- Szeged
- Debrecen
- Debrecen
- Debrecen
- Nyíregyháza
- Budapest
- Budapest
- Budapest
- Lódz
- Lublin
- Lublin
- Lublin
- Kraków
- Warszawa
- Warszawa
- Białystok
- Katowice
- Katowice
- Poznań
- Skórzewo
- Szczecin
- Almada
- Coimbra
- Covilhã
- Lisbon
- Porto
- Port Elizabeth
- Centurion
- Roodepoort
- Durban
- Cape Town
- Madrid
- Valencia
- Kyiv
- Kyiv
- Kyiv
- Chernivtsi
- Ivano-Frankivsk
- Kharkiv
- Kiev
- Kiev
- Kiev
- Vinnytsya
- Zaporizhzhya
- Zaporizhzhya
- Zaporizhzhya
- Zaporizhzhya
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.
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 Dyspareunia NRS Scores At Week 24 Or EOT
Assessed using an NRS score (11-point scale) for dyspareunia 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.
Pre-dose Relugolix Plasma Concentrations
Blood samples will be collected from participants for relugolix measurements.
Endometrial Biopsy At Week 24
Primary diagnosis of endometrial biopsy assessment by pathologist.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03204318
Brief Title
SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Official Title
SPIRIT 1: 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
December 7, 2017 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
April 8, 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 will be 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
638 (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
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 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
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 or EOT
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 or EOT
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
Title
Pre-dose Relugolix Plasma Concentrations
Description
Blood samples will be collected from participants for relugolix measurements.
Time Frame
Week 4
Title
Endometrial Biopsy At Week 24
Description
Primary diagnosis of endometrial biopsy assessment by pathologist.
Time Frame
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
Dothan
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
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
Tucson
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
Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
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
Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Loxahatchee
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
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
Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Oviedo
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
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
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Shawnee
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Jefferson City
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Port Jefferson
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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
Country
United States
Facility Name
Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Murfreesboro
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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
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
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
Córdoba
City
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
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
Sofia
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1233
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
Sofia
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Stara Zagora
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Varna
City
Varna
ZIP/Postal Code
9005
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
Praha 10
City
Praha 10
State/Province
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Nachod
City
Náchod
ZIP/Postal Code
54701
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
Vodnany
City
Vodňany
ZIP/Postal Code
389 01
Country
Czechia
Facility Name
Vysoké Mýto
City
Vysoké Mýto
ZIP/Postal Code
566 01
Country
Czechia
Facility Name
Kuopio
City
Kuopio
State/Province
Eastern Finland
ZIP/Postal Code
FI-70110
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
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
Budapest
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Budapest
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Budapest
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Lódz
City
Lódz
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
20-632
Country
Poland
Facility Name
Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-880
Country
Poland
Facility Name
Kraków
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-121
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
02-929
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
02-066
Country
Poland
Facility Name
Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Poznań
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Skórzewo
City
Skórzewo
State/Province
Wielkopolskie
ZIP/Postal Code
601-85
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
Lisbon
City
Lisbon
ZIP/Postal Code
1069-089
Country
Portugal
Facility Name
Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
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
4001
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
02232
Country
Ukraine
Facility Name
Kyiv
City
Kyiv
State/Province
Kiev City
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Kyiv
City
Kyiv
State/Province
Kiev
ZIP/Postal Code
01034
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
03148
Country
Ukraine
Facility Name
Kiev
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Kiev
City
Kiev
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Vinnytsya
City
Vinnytsya
ZIP/Postal Code
21101
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
Facility Name
Zaporizhzhya
City
Zaporizhzhya
ZIP/Postal Code
69663
Country
Ukraine
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
PubMed Identifier
31069056
Citation
Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019.
Results Reference
derived
Learn more about this trial
SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
We'll reach out to this number within 24 hrs