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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy Related Pregnancy Complications Pregnancy, High Risk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposed Cohort

Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy

Relugolix + Estradiol + Norethindrone Acetate

Intervention Type DRUG

Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)

Unexposed Cohort

Pregnant women with conditions for which relugolix combination therapy could be prescribed, who are not exposed to relugolix combination therapy at any time during pregnancy

No interventions assigned to this group

Interventions

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Relugolix + Estradiol + Norethindrone Acetate

Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)

Intervention Type DRUG

Other Intervention Names

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MVT-601 MVT-601A MYFEMBREE

Eligibility Criteria

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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)