Myovant Sciences initiates Phase III trials, LIBERTY 1 and LIBERTY 2 , of relugolix to treat menstrual bleeding associated with uterine fibroids.

Myovant Sciences announced it has initiated a Phase III clinical program consisting of two international clinical trials, LIBERTY 1 and LIBERTY 2 to evaluate the safety and efficacy of relugolix in women with heavy menstrual bleeding associated with uterine fibroids. Relugolix is an oral, once-daily, small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that decreases estrogen and progesterone. It will be evaluated with and without low-dose hormonal add-back therapy.

LIBERTY 1 and LIBERTY 2 are double-blind, placebo-controlled Phase III international clinical trials in women with heavy menstrual bleeding associated with uterine fibroids that will be conducted at up to 200 sites. Each of the two clinical trials is expected to enroll approximately 390 women aged 18 to 50 years with a diagnosis of uterine fibroids confirmed by ultrasound and heavy menstrual bleeding attributed to uterine fibroids. Eligible women will be randomized to one of three groups: relugolix 40 mg orally once daily co-administered with low-dose hormonal add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate) for 24 weeks, relugolix 40 mg orally once daily monotherapy for 12 weeks followed by relugolix 40 mg once daily co-administered with hormonal add-back therapy for an additional 12 weeks, or placebo once daily for a period of 24 weeks. Patients completing the initial 24-week blinded assessment will be offered an active treatment extension with relugolix 40 mg once daily co-administered with hormonal add-back therapy for an additional 24-week period, or a total treatment period of up to 48 weeks, to evaluate the safety of longer-term treatment.

The primary efficacy outcome of the study is a clinically-meaningful reduction in menstrual blood loss based upon the alkaline hematin method, a standardized centrally-assessed quantitative measurement of menstrual blood loss. Safety outcomes, including bone mineral density changes as measured by dual-energy x-ray absorptiometry, will also be assessed.