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RecruitingNCT05739123

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

Sponsor

Sumitomo Pharma Switzerland GmbH

Enrollment

728 participants

Start Date

May 8, 2023

Study Type

OBSERVATIONAL

Conditions

Pregnancy ComplicationsPregnancy RelatedPregnancy, High Risk

Summary

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.

Eligibility

Sex: FEMALEMin Age: 0 Years

Inclusion Criteria8

  • Woman of any age
  • Currently or recently pregnant
  • Consent to participate
  • Authorization for her HCP(s) to provide data to the registry
  • Cohort 1
  • Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
  • Cohort 2
  • Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy

Exclusion Criteria4

  • The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
  • Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
  • Exposure to known teratogens and/or investigational medications during pregnancy
  • Lost to follow-up

Interventions

DRUGRelugolix-Containing Product

Any relugolix-containing therapy

Locations(1)

PPD

Wilmington, North Carolina, United States

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NCT05739123

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