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

NCT05739136 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 530

Last updated 2025-08-01

No results posted yet for this study

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

Interventions

DRUG

Relugolix + Estradiol + Norethindrone Acetate

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

Sponsors & Collaborators

  • Sumitomo Pharma Switzerland GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05739136 on ClinicalTrials.gov