At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating Relugolix, Estradiol/norethindrone acetate, and 2 other interventions for Heavy Menstrual Bleeding and Uterine Fibroid. Completed, enrolled 388 participants across 110 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Relugolix (40 mg) tablet administered orally once daily.
E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
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.
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.