Clinical trials

We have three clinical programs for relugolix consisting of five international Phase 3 clinical trials, two in women with heavy menstrual bleeding associated with uterine fibroids (LIBERTY 1 & 2), two in women with endometriosis-associated pain (SPIRIT 1 & 2), and one in men with advanced prostate cancer (HERO). We also have one clinical program for MVT-602 consisting of a Ph2a trial in assisted reproduction.

Uterine Fibroids – Heavy Menstrual Bleeding

LIBERTY 1 & 2 are two international, replicate Phase 3 clinical trials evaluating relugolix in women with heavy menstrual bleeding associated with uterine fibroids. Each trial randomizes women 1:1:1 to one of three treatment arms: relugolix 40 mg once daily in combination with estradiol (1.0 mg) and a progestin (0.5 mg norethindrone acetate) for 24 weeks; relugolix 40 mg once daily monotherapy for 12 weeks followed by relugolix 40 mg once daily in combination with estradiol and a progestin for 12 weeks; or placebo once daily for 24 weeks.

Endometriosis – Pain

SPIRIT 1 & 2 are two international, replicate Phase 3 clinical trials evaluating relugolix in women with pain associated with endometriosis. Each trial randomizes women 1:1:1 to one of three treatment arms: relugolix 40 mg once daily in combination with estradiol (1.0 mg) and a progestin (0.5 mg norethindrone acetate) for 24 weeks; relugolix 40 mg once daily monotherapy for 12 weeks followed by relugolix 40 mg once daily in combination with estradiol and a progestin for 12 weeks; or placebo once daily for 24 weeks.

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Advanced Prostate Cancer

HERO is an international, Phase 3 clinical trial evaluating relugolix in men with advanced prostate cancer. This trial randomizes men 2:1 to two treatment arms: relugolix 120 mg once daily monotherapy (after a single loading dose of 360 mg) or a depot injection of leuprolide for at least 48 weeks.

Female Infertility

In a Ph2a trial, MVT-602 is being evaluated during the pre-ovulatory phase in fertile women undergoing controlled ovarian stimulation. This trial will further assess the exposure-response profile of MVT-602 and provide information for dose selection for a study of MVT-602 in women with infertility seeking pregnancy.

Expanded Access

In certain cases, when it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, a patient’s doctor may attempt to seek special access to an investigational drug candidate for that patient outside of a clinical trial. This is known, among other terms, as expanded access. We do not provide expanded access at this time given the availability of other medical options.

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