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Myovant, Pfizer Initiate SERENE Study Evaluating Contraceptive Efficacy Of Relugolix

Myovant Sciences (MYOV) and Pfizer Inc. (PFE) announced Monday that the first participant has been dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in healthy women ages 18-35 years who are at risk for pregnancy.

The SERENE study will enroll 900 sexually active, healthy women under the given age group with presumed normal fertility. Women will receive once-daily relugolix combination tablet for 13 28-day at-risk cycles.

The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. Safety data will also be collected during the study.

Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, said, "The Phase 3 SERENE study is designed to assess the potential of relugolix combination tablet to prevent pregnancy, and will complement data from our Phase 3 LIBERTY and SPIRIT programs which demonstrated the promise of relugolix combination therapy as a potential treatment for uterine fibroids and endometriosis."

Relugolix combination tablet is under review by the U.S. Food and Drug Administration for the treatment of women with uterine fibroids, with a decision expected by the June 1 target action date. The submission of a New Drug Application for the treatment of moderate to severe pain associated with endometriosis is anticipated in the first half of 2021.

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