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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739123
• Other study ID #: MVT-601A-002
• Status: Recruiting
• Start date: May 8, 2023
• Est. completion date: May 2033

Study information

• Verified date: March 2024
• Source: Sumitomo Pharma Switzerland GmbH
• Contact: Clinical Trials at Myovant
• Phone: 650-278-8743
• Email: ClinicalTrials[@]Myovant.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 728
• Est. completion date: May 2033
• Est. primary completion date: May 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Pregnancy Related
• Pregnancy, High Risk

Intervention

Drug:
• Relugolix-Containing Product
Any relugolix-containing therapy

Locations

Country	Name	City	State
United States	PPD	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Switzerland GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Congenital Malformation (MCM)	Comparison of rate of MCM between cohorts	Up to 10 years
Secondary	Minor congenital malformations	Comparison of rate of minor congenital malformations between cohorts	Up to 10 years
Secondary	Spontaneous abortion (SAB)	Comparison of rate of SABs between cohorts	Up to 10 years
Secondary	Stillbirth	Comparison of rate of stillbirths between cohorts	Up to 10 years
Secondary	Elective termination	Comparison of rate of elective terminations between cohorts	Up to 10 years
Secondary	Preterm birth	Comparison of rate of preterm births between cohorts	Up to 10 years
Secondary	Small for gestational age (SGA)	Comparison of rate of SGA between cohorts	Up to 10 years
Secondary	Postnatal growth deficiency	Comparison of rate of postnatal growth deficiency between cohorts	Up to 10 years
Secondary	Infant developmental deficiency	Comparison of rate of infant developmental deficiency between cohorts	Up to 10 years