NCT05739136

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 530 (estimated)
• Sponsor: Sumitomo Pharma Switzerland GmbH · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs. Anticipated enrollment is 530 live births.

Conditions

• Pregnancy Related
• Pregnancy Complications
• Pregnancy, High Risk

Interventions

Type	Name	Description
DRUG	Relugolix + Estradiol + Norethindrone Acetate	Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-02-22
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study