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

NCT05739123 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 728

Last updated 2025-08-19

No results posted yet for this study

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

Interventions

DRUG

Relugolix-Containing Product

Any relugolix-containing therapy

Sponsors & Collaborators

  • Sumitomo Pharma Switzerland GmbH

    lead INDUSTRY

Eligibility

Min Age
0 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2033-05-31
Completion
2033-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05739123 on ClinicalTrials.gov