NCT05739123Recruiting
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 728 (estimated)
- First submitted
- 13 Feb 2023
- Start date
- 8 May 2023
- Primary completion date
- May 2033
- Lead sponsor
- Sumitomo Pharma Switzerland GmbH
- Diseases
- Endometriosis
- NCT number
- NCT05739123
What you commit to
- Study type: Observational
- Planned participants: 728
- From 8 May 2023 to the primary completion date, May 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
- Lost to follow-up
Who the study is looking for
- 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
Age in the registry: 0 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PPD Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.