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

Last updated: May 14, 2024
Sponsor: Sumitomo Pharma Switzerland GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Relugolix-Containing Product

Clinical Study ID

NCT05739123
MVT-601A-002
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 duringpregnancy

Cohort 2

  • Diagnosis of a condition for which relugolix-containing therapy may be prescribedand who are not exposed to relugolix containing therapy at any time during pregnancy

Exclusion

Exclusion Criteria:

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 registrycoordination center (retrospectively enrolled)

  • Exposure to known teratogens and/or investigational medications during pregnancy

  • Lost to follow-up

Study Design

Total Participants: 728
Treatment Group(s): 1
Primary Treatment: Relugolix-Containing Product
Phase:
Study Start date:
May 08, 2023
Estimated Completion Date:
May 31, 2033

Study Description

The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency.

Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.

The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.

Connect with a study center

  • PPD

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

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