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

NCT05739136 | Active Not Recruiting FDA Drug

• 1 other identifier: MVT-601A-003
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Pregnancy Complications; Pregnancy, High Risk

Keywords

Relugolix; Uterine Fibroids; Endometriosis; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Major Congenital Malformation (MCM)

  Comparison of rate of MCM between cohorts

  Up to 5 years

Secondary Outcomes (4)

• Spontaneous abortion (SAB)

  Up to 5 years

• Stillbirth

  Up to 5 years

• Preterm birth

  Up to 5 years

• Small for gestational age (SGA)

  Up to 5 years

Study Arms (2)

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

Drug: Relugolix + Estradiol + Norethindrone Acetate

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

Interventions

Relugolix + Estradiol + Norethindrone Acetate DRUG

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

Also known as: MVT-601, MVT-601A, MYFEMBREE

Exposed Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include 2 cohorts: The exposed cohort will include pregnant women with conditions for which relugolix combination therapy is prescribed and who are exposed to relugolix combination therapy at any time during pregnancy. The unexposed cohort will include pregnant women with conditions for which relugolix combination therapy could be prescribed and who are not exposed to relugolix combination therapy at any time during pregnancy.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Sumitomo Pharma Switzerland GmbH: lead

Study Sites (1)

SMPA

Marlborough, Massachusetts, 01752, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Leiomyoma; Endometriosis

Interventions

relugolix; Estradiol; Norethindrone Acetate

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norethindrone; Norpregnenes; Norpregnanes; Norsteroids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)