Actively Recruiting
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Led by Sumitomo Pharma Switzerland GmbH · Updated on 2025-08-19
728
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman of any age
- Currently or recently pregnant
- Consent to participate
- Authorization for her healthcare providers to provide data to the registry
- For Cohort 1, exposure to at least one dose of relugolix-containing therapy during pregnancy
- For Cohort 2, diagnosed with a condition possibly treated with relugolix but not exposed to it during pregnancy
You will not qualify if you...
- Pregnancy outcome occurred before first contact with the registry coordination center (retrospective enrollment)
- Exposure to known teratogens or investigational medications during pregnancy
- Lost to follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
PPD
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
C
Clinical Trials at Myovant
CONTACT
M
Myovant Medical Monitor Study Director
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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