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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Pregnancy Related; Pregnancy, High Risk
• Intervention / Treatment: Drug: Relugolix-Containing Product

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 728

Contacts and Locations

• Study Contact: Name: Myovant Medical Monitor Study Director
• Study Contact Backup: Name: Clinical Trials at Myovant; Phone Number: 650-278-8743; Email: ClinicalTrials@Myovant.com

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • PPD
      • Contact: Ronna L Chan, PH.D., M.P.H.; Phone Number: 919-270-6678
      • Principal Investigator: Ronna L Chan, PH.D, M.P.H.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include 2 cohorts of pregnant women: one cohort exposed to relugolix-containing therapy and one cohort of women with conditions for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix-containing therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed Cohort; Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy	Drug: Relugolix-Containing Product; Any relugolix-containing therapy; Other Names: TAK-385; MVT-601; RVT-601; T-1331285; MVT-601A; MYFEMBREE
Unexposed Cohort; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Congenital Malformation (MCM)	Comparison of rate of MCM between cohorts	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor congenital malformations	Comparison of rate of minor congenital malformations between cohorts	Up to 10 years
Spontaneous abortion (SAB)	Comparison of rate of SABs between cohorts	Up to 10 years
Stillbirth	Comparison of rate of stillbirths between cohorts	Up to 10 years
Elective termination	Comparison of rate of elective terminations between cohorts	Up to 10 years
Preterm birth	Comparison of rate of preterm births between cohorts	Up to 10 years
Small for gestational age (SGA)	Comparison of rate of SGA between cohorts	Up to 10 years
Postnatal growth deficiency	Comparison of rate of postnatal growth deficiency between cohorts	Up to 10 years
Infant developmental deficiency	Comparison of rate of infant developmental deficiency between cohorts	Up to 10 years

Collaborators and Investigators

• Sponsor: Sumitomo Pharma Switzerland GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): May 1, 2033

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Endometriosis; Uterine Fibroids; Relugolix
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Relugolix
• Other Study ID Numbers: MVT-601A-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes