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

NCT03103087 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Myovant Sciences GmbH
Phase	PHASE3
Status	COMPLETED
Enrolment	382
Start date	Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Sep 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Heavy Menstrual Bleeding
• Uterine Fibroid

Interventions

• Relugolix
• Estradiol/norethindrone acetate
• Relugolix placebo
• Estradiol/norethindrone acetate placebo

Countries

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