NCT05739123

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
728

participants targeted

Target at P75+ for all trials

Timeline
85mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
May 2023May 2033

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2033

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

February 13, 2023

Last Update Submit

August 14, 2025

Conditions

Pregnancy RelatedPregnancy ComplicationsPregnancy, High Risk

Keywords

RelugolixUterine FibroidsEndometriosisPregnancy

Outcome Measures

Primary Outcomes (1)

  • Major Congenital Malformation (MCM)

    Comparison of rate of MCM between cohorts

    Up to 10 years

Secondary Outcomes (8)

  • Minor congenital malformations

    Up to 10 years

  • Spontaneous abortion (SAB)

    Up to 10 years

  • Stillbirth

    Up to 10 years

  • Elective termination

    Up to 10 years

  • Preterm birth

    Up to 10 years

  • +3 more secondary outcomes

Study Arms (2)

Exposed Cohort

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

Drug: Relugolix-Containing Product

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 ProductDRUG

Any relugolix-containing therapy

Also known as: TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE
Exposed Cohort

Eligibility Criteria

Age0 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD

Wilmington, North Carolina, 28401, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy ComplicationsLeiomyomaEndometriosis

Interventions

relugolix

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Central Study Contacts

Clinical Trials at Myovant

CONTACT

650-278-8743ClinicalTrials@Myovant.com

Myovant Medical Monitor Study Director

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 22, 2023

Study Start

May 8, 2023

Primary Completion (Estimated)

May 1, 2033

Study Completion (Estimated)

May 1, 2033

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations

US(1)