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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

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2025 to Apr 30, 2025
    v5
  2. Lead sponsor: Myovant Sciences GmbH to Sumitomo Pharma Switzerland GmbHv4
  3. Start date: Jun 2023 to Jan 2025
    • Study description expanded, about 6 words
    v3
  4. Start date: Feb 2023 to Jun 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05739136
Lead Sponsor Sumitomo Pharma Switzerland GmbH
Conditions
(from sponsor)		 Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
Related terms Endometriosis, Leiomyoma, Pregnancy Complications
Enrollment 530 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov