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Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. 2 versions Re-verified since Jul 30, 2025, no change to tracked fieldsv7-v8
  2. Site contact updatedv6
  3. Lead sponsor: Myovant Sciences GmbH to Sumitomo Pharma Switzerland GmbHv5
  4. Eligibility criteria expanded, about 2 wordsv4
  5. Start date changed from estimate of Mar 2023 to May 8, 2023v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Feb 2023 to Mar 2023
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.
Trial Details
NCT Number NCT05739123
Lead Sponsor Sumitomo Pharma Switzerland GmbH
Conditions
(from sponsor)		 Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
Related terms Endometriosis, Leiomyoma, Pregnancy Complications
Enrollment 728 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov