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

Sumitomo Pharma

Status: Enrolling

Conditions: Pregnancy Complications; Pregnancy Related; Pregnancy, High Risk

Treatments: Drug: Relugolix-Containing Product

Study type: Observational

Funder types: Industry

Identifiers

NCT05739123

MVT-601A-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 728 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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 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 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 registry coordination center (retrospectively enrolled)
• Exposure to known teratogens and/or investigational medications during pregnancy
• Lost to follow-up

Trial design

728 participants in 2 patient groups

Exposed Cohort

Description:

Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy

Treatment:

Drug: Relugolix-Containing Product

Unexposed Cohort

Description:

Pregnant women with conditions for which relugolix-containing therapy may be prescribed for indications that are approved or under phase 3 development and who are not exposed to relugolix-containing therapy at any time during pregnancy