Status and phase
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About
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
Full description
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).
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
1,020 participants in 1 patient group
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Central trial contact
Myovant Medical Monitor Study Director; Clinical Trials at Myovant
Data sourced from clinicaltrials.gov
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