LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Conditions

• Heavy Menstrual Bleeding
• Uterine Fibroid

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Relugolix — DRUG
  Relugolix 40-mg tablet administered orally once daily
• Estradiol/norethindrone acetate — DRUG
  Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily

Study Details

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).

Key Dates

Start date

Oct 19, 2017

Status verified

Apr 2024

Primary completion

Jan 21, 2020

Completion

Jan 13, 2021

Study Design

Enrollment

477 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix plus E2/NETA
  Relugolix co-administered with E2/NETA for 28 weeks.

Primary Outcome Measure

Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment [ Time Frame: Week 52/End of Treatment ]

Locations (104)

Find similar trials in Andalusia, AL

Related Studies

• Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
  Recruiting · InSightec · Los Angeles, California
• Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
  Recruiting · Oregon Health and Science University · Palo Alto, California
• A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
  Recruiting · Channel Medsystems · West Orange, New Jersey
• Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
  Recruiting · Merit Medical Systems, Inc. · Brooklyn, New York