logo
  

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Hedge-fund billionaire William Ackman's Pershing Square Tontine Holdings Ltd. (PSTH) agreed to acquire 10% of Universal Music Group from French media conglomerate Vivendi (VIV.L, VIVEF.PK) for about $4 billion, the companies said in a statement on Sunday. The 737 MAX 10, Boeing Co.'s largest 737 Max model, is taking its maiden flight today, reports said citing people familiar with the matter. The flight after months of testing and certification will be around 10 a.m. local time from the Seattle area. The schedule could change depending on weather or other factors. Meanwhile, the jetliner is expected to enter commercial service in 2023. Medical devices supplier Smiths Medical, affiliated to Smiths Group plc, is recalling certain Jelco Hypodermic Needle-Pro Fixed Needle insulin syringes with skewed graduation markings, the U.S. Food and Drug Administration said. The recall was initiated after the company became aware of specific models and lots of Jelco insulin syringes that may exhibit skewed odd number line graduation markings.
Follow RTT