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NCT03654274 · ClinicalTrials.gov registry record · Phase 3
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
A Phase 3 study of Endometriosis, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
- 20
- Study locations
NCT03654274: Completed Phase 3 study of Endometriosis, sponsored by Myovant Sciences.
NCT03654274 is a Phase 3 study of Endometriosis that has completed, run by Myovant Sciences. The registered enrollment target is 802 participants, above the 248-participant average among 48 other Endometriosis trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654274, a Phase 3 study of Endometriosis, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
Study Locations (20)
Florida
- Aventura - Aventura
- Fort Myers - Fort Myers
- Hialeah - Hialeah
- Hialeah - Hialeah
- Margate - Margate
- Miami - Miami
- Miami - Miami
- Sarasota - Sarasota
- Tampa - Tampa
Arizona
- Scottsdale - Scottsdale
- Tucson - Tucson
- Tuscon - Tucson
California
- Canoga Park - Canoga Park
- Los Angeles - Los Angeles
- San Diego - San Diego
Georgia
- Atlanta - Atlanta
- Atlanta - Atlanta
Alabama
- Andalusia - Andalusia
Colorado
- Greenwood Village - Greenwood Village
District of Columbia
- Washington - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2018-05-22 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 3 |
What the finished NCT03654274 record still lists
NCT03654274 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, above the 248-participant average among 48 other Endometriosis trials with a reported enrollment target (223% higher).
The record links to 1 condition, with Endometriosis appearing as the primary indexed condition, and to 2 interventions - of which Relugolix is the first listed.
NCT03654274 names 20 study sites across 7 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT03654274 about?
NCT03654274 is a clinical study titled "SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain". 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 t...
What is the current status of trial NCT03654274?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2018-05-22. Estimated completion is 2023-01-31.
What conditions does trial NCT03654274 study?
This clinical trial studies the following conditions: Endometriosis.
What interventions are being tested in trial NCT03654274?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG).
Who is sponsoring clinical trial NCT03654274?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03654274 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometriosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03654274's enrollment target sits among peer trials
802 6th of 48 higher than 43 of 48 other Endometriosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometriosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp
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Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
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A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
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Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain
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Medical Treatment of Endometriosis-Associated Pelvic Pain
COMPLETED · Phase 3
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