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

NCT03103087 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2022-04-20

Study results available
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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

  • Heavy Menstrual Bleeding
  • Uterine Fibroid

Interventions

DRUG

Relugolix

Relugolix (40 mg) tablet administered orally once daily.

DRUG

Estradiol/norethindrone acetate

E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.

DRUG

Relugolix placebo

Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

DRUG

Estradiol/norethindrone acetate placebo

E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.

Sponsors & Collaborators

  • Myovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Myovant Medical Monitor · Myovant Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2019-07-10
Completion
2020-09-16
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Chile
  • Czechia
  • Hungary
  • Poland
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103087 on ClinicalTrials.gov