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NCT03103087 · ClinicalTrials.gov registry record · Phase 3

LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

A Phase 3 study of Heavy Menstrual Bleeding and Uterine Fibroid, sponsored by Myovant Sciences.

Completed
Registry status
Phase 3
Development phase
382
Enrollment target
20
Study locations

NCT03103087 is a Phase 3 study of Heavy Menstrual Bleeding and Uterine Fibroid that has completed, run by Myovant Sciences. The registered enrollment target is 382 participants, above the 183-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT03103087, a Phase 3 study of Heavy Menstrual Bleeding and Uterine Fibroid, has completed, sponsored by Myovant Sciences.

COMPLETED
Registry status
Phase 3
Development phase
382 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Heavy Menstrual Bleeding Uterine Fibroid

Interventions

  • DRUG Relugolix
  • DRUG Estradiol/norethindrone acetate
  • DRUG Relugolix placebo
  • DRUG Estradiol/norethindrone acetate placebo

Study Locations (20)

California

  • Canoga Park - Canoga Park
  • Huntington Beach - Huntington Beach
  • Long Beach - Long Beach
  • Los Angeles - Los Angeles
  • Los Angeles - Los Angeles
  • Panorama - Panorama City
  • San Diego - San Diego
  • Upland - Upland

Florida

  • Aventura - Aventura
  • DeLand - DeLand
  • Ft. Lauderdale - Fort Lauderdale
  • Jupiter - Jupiter
  • Lake City - Lake City

Arizona

  • Mesa - Mesa
  • Tucson - Tucson
  • Tuscon - Tucson

Colorado

  • Denver - Denver
  • Lakewood - Lakewood

Alabama

  • Birmingham - Birmingham

District of Columbia

  • Washington - Washington D.C.

Trial Details

FieldValue
Enrollment Target 382 participants
Start Date 2017-06-14
Est. Completion 2020-09-16
Phase Phase 3

Sponsor

Myovant Sciences

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03103087

The ClinicalTrials.gov registry entry for NCT03103087 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 183-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (109% higher). The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heavy Menstrual Bleeding appearing as the primary indexed condition, and to 4 interventions - of which Relugolix is the first listed.

NCT03103087 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT03103087 about?

NCT03103087 is a clinical study titled "LIBERTY 2: 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 NCT03103087?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2017-06-14. Estimated completion is 2020-09-16.

What conditions does trial NCT03103087 study?

This clinical trial studies the following conditions: Heavy Menstrual Bleeding, Uterine Fibroid.

What interventions are being tested in trial NCT03103087?

The interventions under investigation include: Relugolix (DRUG), Estradiol/norethindrone acetate (DRUG), Relugolix placebo (DRUG), Estradiol/norethindrone acetate placebo (DRUG).

Who is sponsoring clinical trial NCT03103087?

This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03103087 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.