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NCT03204331 · ClinicalTrials.gov registry record · Phase 3
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
A Phase 3 study, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 623
- Enrollment target
NCT03204331: Completed Phase 3 study, sponsored by Myovant Sciences.
NCT03204331 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 623 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03204331, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 623 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
- DRUG Relugolix placebo
- DRUG Estradiol/norethindrone acetate placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 623 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 3 |
What the finished NCT03204331 record still lists
NCT03204331 is an interventional study that assigns participants to a tested intervention. The registered 623 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 4 interventions - of which Relugolix is the first listed.
NCT03204331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03204331 about?
NCT03204331 is a clinical study titled "SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain". 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.
What is the current status of trial NCT03204331?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 623 participants. The study started on 2017-11-01. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT03204331?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG), Relugolix placebo (DRUG), Estradiol/norethindrone acetate placebo (DRUG).
Who is sponsoring clinical trial NCT03204331?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03204331's enrollment target sits among peer trials
623 588th of 2000 higher than 1,413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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