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NCT Number: NCT05739136

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pregnancy Complications Pregnancy, High Risk Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

SMPA

Marlborough, Massachusetts, 01752, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relugolix + Estradiol + Norethindrone Acetate

Drug

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

Other names: MVT-601, MVT-601A, MYFEMBREE

Primary outcomes

  1. Major Congenital Malformation (MCM)

    Time frame: Up to 5 years

    Comparison of rate of MCM between cohorts

Secondary outcomes

  1. Spontaneous abortion (SAB)

    Time frame: Up to 5 years

    Comparison of rate of SABs between cohorts

  2. Stillbirth

    Time frame: Up to 5 years

    Comparison of rate of stillbirths between cohorts

  3. Preterm birth

    Time frame: Up to 5 years

    Comparison of rate of preterm births between cohorts

  4. Small for gestational age (SGA)

    Time frame: Up to 5 years

    Comparison of rate of SGA between cohorts

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Switzerland GmbH

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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