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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Major Congenital Malformation (MCM) — Up to 5 years Comparison of rate of MCM between cohorts
Trial sites (1)
Facility
City
Region
Status
SMPA
Marlborough
Massachusetts
More Sumitomo Pharma Switzerland GmbH trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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