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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.

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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

FieldValue
Enrollment Target 388 participants
Start Date 2017-04-26
Est. Completion 2020-08-24
Phase Phase 3

Sponsor

Myovant Sciences

11 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.