A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy
A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and norethindrone acetate [NETA] 0.5 mg).
Key Inclusion Criteria:
Is a premenopausal woman, 18 to 50 years of age.
Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception.
Has normal, regular menstrual cycles that are between 21 and 35 days in duration.
Has a diagnosis of uterine fibroids or endometriosis meeting either of the following criteria:
Is willing to use the study intervention as the sole method of contraception for 13 consecutive 28-day treatment cycles and does not intend to use any other form of contraception (for example, condoms).
Key Exclusion Criteria: