Recruiting

Relugolix

Sponsor:

Sumitomo Pharma Switzerland GmbH

Code:

NCT05739123

Conditions

Pregnancy Related

Pregnancy Complications

Pregnancy, High Risk

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Relugolix-Containing Product

Study Details

Brief 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.

Conditions

Pregnancy Related

Pregnancy Complications

Pregnancy, High Risk

Study ID

NCT05739123

Start date

May 8, 2023

Status verified date

Aug, 2025

Completion date

May, 2033

Anticipated

Primary completion date

May, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

728 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed Cohort

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

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

Interventions

Relugolix-Containing Product

Any relugolix-containing therapy

Primary outcome measure

  • Major Congenital Malformation (MCM) [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Clinical Trials at Myovant

650-278-8743ClinicalTrials@Myovant.com

Locations

PPD

Recruiting

Wilmington, North Carolina, United States, 28401

Contacts

Ronna L Chan, PH.D., M.P.H.

919-270-6678

Principal Investigator:

Ronna L Chan, PH.D, M.P.H.

More Information

Sponsor

Sumitomo Pharma Switzerland GmbH

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • Relugolix
  • Uterine Fibroids
  • Endometriosis
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sumitomo Pharma Switzerland GmbH on 2025-08-19.