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NCT03049735 · ClinicalTrials.gov registry record · Phase 3
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 study, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 388
- Enrollment target
NCT03049735 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 388 participants.
The verdict
NCT03049735, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 388 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
- DRUG Relugolix placebo
- DRUG Estradiol/norethindrone acetate placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2017-04-26 |
| Est. Completion | 2020-08-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03049735
The ClinicalTrials.gov registry entry for NCT03049735 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 388 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.
NCT03049735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03049735 about?
NCT03049735 is a clinical study titled "LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids". The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
What is the current status of trial NCT03049735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 388 participants. The study started on 2017-04-26. Estimated completion is 2020-08-24.
What interventions are being tested in trial NCT03049735?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG), Relugolix placebo (DRUG), Estradiol/norethindrone acetate placebo (DRUG).
Who is sponsoring clinical trial NCT03049735?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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