Active — Not RecruitingNot Applicable

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

United States530 participantsStarted 2025-04-30

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Major Congenital Malformation (MCM)

Timeframe: Up to 5 years

Trial details

NCT IDNCT05739136

SponsorSumitomo Pharma Switzerland GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Pregnancy Related trials