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MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
Sponsor: Sumitomo Pharma Switzerland GmbH
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
530
Start Date
2025-04-30
Completion Date
2027-05
Last Updated
2025-08-01
Healthy Volunteers
No
Interventions
Relugolix + Estradiol + Norethindrone Acetate
Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)
Locations (1)
SMPA
Marlborough, Massachusetts, United States