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NCT03412890 · ClinicalTrials.gov registry record · Phase 3
LIBERTY EXTENSION: Efficacy and Safety Extension 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
- 477
- Enrollment target
NCT03412890 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 477 participants.
The verdict
NCT03412890, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 477 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).
Interventions
- DRUG Relugolix
- DRUG Estradiol/norethindrone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03412890
The ClinicalTrials.gov registry entry for NCT03412890 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 477 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 2 interventions - of which Relugolix is the first listed.
NCT03412890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03412890 about?
NCT03412890 is a clinical study titled "LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids". The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously comple...
What is the current status of trial NCT03412890?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 477 participants. The study started on 2017-10-19. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT03412890?
The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG).
Who is sponsoring clinical trial NCT03412890?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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