Date: 2017-01-25
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Myovant Sciences (Switzerland)
Product: relugolix
Action
mechanism: GnRH receptor antagonist. Relugolix is an oral, once-daily, potential best-in-class gonadotropin-releasing hormone (GnRH) receptor antagonist for uterine fibroids, endometriosis and prostate cancer. By inhibiting GnRH receptors in the pituitary gland, relugolix rapidly reduces circulating sex hormone levels leading to suppression of estrogen and testosterone. Suppression of these sex hormones improves the symptoms of women with uterine fibroids and endometriosis, and decreases prostate-specific antigen (PSA) levels in men with prostate cancer.
Disease: heavy menstrual bleeding associated with uterine fibroids
Therapeutic area: Women health
Country: USA
Trial
details: The purpose of this phase 3 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. (NCT03049735)
Latest
news: * On January 25, 2017, Myovant Sciences announced it has initiated a Phase 3 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 will be evaluated with and without low-dose hormonal add-back therapy.
LIBERTY 1 and LIBERTY 2 are double-blind, placebo-controlled Phase 3 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.
Myovant intends to initiate five Phase 3 clinical trials for relugolix in 2017. In the first half of the year, the company plans to initiate two international Phase 3 trials for relugolix co-administered with and without low-dose hormonal add-back therapy in women with endometriosis-associated pain. In addition, Myovant anticipates launching an international Phase 3 clinical trial for relugolix in men with advanced prostate cancer during the first quarter of 2017.
