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

MVT-601A-003

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.

2025-01-01

2027-05-01

2027-05-01

Not yet recruiting

530

Inclusion Criteria: * Woman ≥ 18 and ≤ 50 years of age at time of conception * Diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception) Cohort 1 * Exposure to relugolix combination therapy at any time during pregnancy Cohort 2 * No 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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 530, 'type': 'ESTIMATED'}}

2024-03-08