Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Recruiting · NCT05739123 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sumitomo Pharma Switzerland GmbH
View the official record on ClinicalTrials.gov →Interventions studied
Relugolix-Containing Product
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.
Who can take part
Age range
0 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy
Exclusion criteria
- The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
- 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
- Lost to follow-up
Where it is running
1 location listed across 1 US state.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →