Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Recruiting
Observational Study
Pregnancy Related
Pregnancy Complications
Pregnancy, High Risk
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 0 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 728 (estimated)
- Sponsor
- Sumitomo Pharma Switzerland GmbH · Industry
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About This Trial
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 Locations
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Eligibility Criteria
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 conditi…
Contacts
Myovant Medical Monitor Study Director
CONTACT