Clinical trial · Observational
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
NCT05739123CI-TRIAL-00093858recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pregnancy Complications | — | UNRESOLVED | — |
| Pregnancy, High Risk | — | UNRESOLVED | — |
| Pregnancy Related | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relugolix-Containing Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Exposed Cohort
- description
- Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy
- interventionNames
- Drug: Relugolix-Containing Product
- label
- Unexposed Cohort
- description
- Pregnant women with conditions for which relugolix-containing therapy may be prescribed for indications that are approved or under phase 3 development and who are not exposed to relugolix-containing therapy at any time during pregnancy
Primary outcomes (1)
- measure
- Major Congenital Malformation (MCM)
- timeFrame
- Up to 10 years
- description
- Comparison of rate of MCM between cohorts
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 0 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.