Tracks pregnancy and infant outcomes after relugolix-containing therapy exposure
Observes pregnant women exposed to relugolix-containing therapy and their babies.
Plain-language title generated from the registry record
Registry title: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Key facts
- Where
- Wilmington, United StatesSee the site
Where in United States
- PPDWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sumitomo Pharma Switzerland GmbH
- Trial code
- NCT05739123
- Record updated
- 19 August 2025
- Original description
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.Read full original descriptionShow less
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
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.
Inclusion: 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: 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; The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:; Lost to follow-up.