April 12, 2021: “Myovant Sciences and Pfizer Inc. announced 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.
“We are committed to redefining care for women, which means supporting their overall health and quality of life.
Many women with uterine fibroids and endometriosis need to simultaneously manage their symptoms and their reproductive choices – including prevention of pregnancy,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc.
“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.”
The SERENE study will enroll 900 sexually active, healthy women ages 18-35 years with presumed normal fertility.
The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment.
On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including seven days after the last intake of study medication.
Women will receive once-daily relugolix combination tablet for 13 28-day at-risk cycles. Safety data will also be collected during the study.
“The findings of the Phase 1 study demonstrated that relugolix combination therapy inhibited ovulation in all the study participants and provided the basis for the SERENE study to evaluate whether relugolix combination tablet has the potential to prevent pregnancy in women receiving therapy,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer.
“The data from this Phase 3 study will provide important information to patients and healthcare providers when making treatment decisions for women with endometriosis and uterine fibroids.”
In April 2020, Myovant announced results from a Phase 1 single-arm, open-label ovulation inhibition study to assess the effects of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) on ovulation inhibition, per the Hoogland-Skouby assessment scale (score < 5).
In 67 healthy women over an 84-day treatment period (three cycles), relugolix combination therapy achieved 100% ovulation inhibition and was generally well tolerated.
Furthermore, 100% of women resumed ovulation or menses upon discontinuation of treatment, with an average time to ovulation of 23.5 days. Data from this study were previously presented at the American Society for Reproductive Medicine 2020 Virtual Congress.
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, 2021 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.”
https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-announce-first-participant
