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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responder

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
Myovant Sciences

11 total trials

What the finished NCT03103087 record still lists

NCT03103087 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 183-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (109% higher).

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 names 20 study sites across 6 states, led by 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.

Learn More About Clinical Trials

Similar trials for Heavy Menstrual Bleeding

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03103087's enrollment target sits among peer trials

382 2nd of 9 the highest of 9 other Heavy Menstrual Bleeding trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heavy Menstrual Bleeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03103087, the US trial registry maintained by the National Library of Medicine. NCT03103087 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.