Last updated on September 2017

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


Brief description of study

The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks in the same population.

Detailed Study 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 estradiol and norethindrone acetate (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 estradiol and norethindrone acetate (Group B) compared with 24 weeks of placebo (Group C). Approximately 390 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled in the study and will participate for approximately 10 months. Participation will include an ~ 11 week screening period, 24 weeks of treatment and a follow up period of ~ 30 days. A diagnosis of uterine fibroids will be confirmed during the screening period by centrally-reviewed transvaginal and/or transabdominal ultrasound. Following successful completion of the Screening period study participants will be randomized to Treatment Group A, B, or C and will attend visits monthly (ie, every 4 weeks). 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. All patients completing the Week 24 visit, including women randomized to placebo, will be offered the opportunity to enroll in an open-label extension study in which all eligible patients will receive relugolix co-administered with low-dose estradiol and norethindrone acetate. Patients who do not enroll into the extension study will have a follow-up visit approximately 30 days after the end of treatment (ie, after the patient's last dose of study medication).

Clinical Study Identifier: NCT03103087

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Clinical Trials at Myovant

Tuscon
Tucson, AZ United States
  Connect »