LIBERTY 2: Efficacy & Safety 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
  E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
• Relugolix placebo — DRUG
  Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
• Estradiol/norethindrone acetate placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 14, 2017

Status verified

Sep 2021

Primary completion

Jul 10, 2019

Completion

Sep 16, 2020

Study Design

Enrollment

382 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix plus E2/NETA (Group A)
  Relugolix co-administered with E2/NETA for 24 weeks.
• Experimental: Relugolix plus Delayed E2/NETA (Group B)
  Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
• Placebo Comparator: Placebo (Group C)
  Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.

Primary Outcome Measure

Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA [ Time Frame: From Baseline up to the last 35 days of treatment (up to Week 24) ]

Locations (89)

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