MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.

Inclusion Criteria:Woman ≥ 18 and ≤ 50 years of age at time of conceptionDiagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception)Cohort 1Exposure to relugolix combination therapy at any time during pregnancyCohort 2No exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy)Exclusion Criteria:Exposure to known teratogens during pregnancy< 6 months of continuous healthcare coverage immediately prior to date of conception