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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 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 638 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03204318
The ClinicalTrials.gov registry entry for NCT03204318 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 638 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Relugolix is the first listed.
NCT03204318 reports 0 study locations.
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.
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