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NCT03204318 · ClinicalTrials.gov registry record · Phase 3
SPIRIT 1: 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
- 638
- Enrollment target
NCT03204318: Completed Phase 3 study, sponsored by Myovant Sciences.
NCT03204318 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 638 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03204318, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 638 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 | 638 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2021-04-08 |
| Phase | Phase 3 |
What the finished NCT03204318 record still lists
NCT03204318 is an interventional study that assigns participants to a tested intervention. The registered 638 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 (17% lower).
The record links to 0 conditions, and to 4 interventions - of which Relugolix is the first listed.
NCT03204318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03204318 about?
NCT03204318 is a clinical study titled "SPIRIT 1: 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 NCT03204318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 638 participants. The study started on 2017-12-07. Estimated completion is 2021-04-08.
What interventions are being tested in trial NCT03204318?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG), Relugolix placebo (DRUG), Estradiol/norethindrone acetate placebo (DRUG).
Who is sponsoring clinical trial NCT03204318?
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 NCT03204318's enrollment target sits among peer trials
638 579th of 2000 higher than 1,422 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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