NCT03103087

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

LIBERTY 2: 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Myovant Sciences GmbH · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with low-dose E2 and NETA (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by 12 weeks of daily oral relugolix 40 mg co-administered with low-dose E2 and NETA (Group B) compared with 24 weeks of placebo (Group C). All participants completing the Week 24 visit, including participants randomized to placebo, were offered the opportunity to enroll in an open-label extension study in which all eligible participants will receive relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the end of treatment (that is, after the participant's last dose of study medication). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.

Conditions

• Heavy Menstrual Bleeding
• Uterine Fibroid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-14
• Primary completion: 2019-07-10
• Completion: 2020-09-16
• First posted: 2017-04-06
• Last updated: 2022-04-20
• Results posted: 2022-04-20

Locations

127 sites across 8 countries: United States, Belgium, Brazil, Chile, Czechia, Hungary, Poland, South Africa

Regulatory

• FDA-regulated drug study