LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT03049735 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	388
Start date	Wed Apr 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Aug 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Heavy Menstrual Bleeding
• Uterine Fibroid

Interventions

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

Countries

Italy, South Africa, United Kingdom, Poland, United States, Brazil