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

Not yet recruiting

• Conditions: Pregnancy Related; Pregnancy Complications; Pregnancy, High Risk
• Interventions: Drug: Relugolix + Estradiol + Norethindrone Acetate

• Registration Number: NCT05739136
• Lead Sponsor: Sumitomo Pharma Switzerland GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Study Start: 2025-01
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 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)

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Exclusion Criteria

• Exposure to known teratogens during pregnancy
• < 6 months of continuous healthcare coverage immediately prior to date of conception

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed Cohort	Relugolix + Estradiol + Norethindrone Acetate	Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy

Primary Outcome Measures

Name	Time	Method
Major Congenital Malformation (MCM)	Up to 5 years	Comparison of rate of MCM between cohorts

Secondary Outcome Measures

Name	Time	Method
Spontaneous abortion (SAB)	Up to 5 years	Comparison of rate of SABs between cohorts
Small for gestational age (SGA)	Up to 5 years	Comparison of rate of SGA between cohorts
Stillbirth	Up to 5 years	Comparison of rate of stillbirths between cohorts
Preterm birth	Up to 5 years	Comparison of rate of preterm births between cohorts