Observational study on the safety of relugolix therapy in pregnant women
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
This study is trying to see if relugolix therapy is safe for pregnant women and their babies by looking at health outcomes during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 728 (estimated) |
| Ages | 0 Years and up |
| Sex | Female |
| Sponsor | Sumitomo Pharma Switzerland GmbH Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT05739123 on ClinicalTrials.gov |
What this trial studies
The Relugolix Pregnancy Registry is a prospective observational cohort study aimed at evaluating the safety of relugolix-containing therapy during pregnancy. It will collect data on maternal, fetal, and infant outcomes from pregnant women who have been exposed to this therapy, as well as from those who have not but have a relevant diagnosis. Outcomes of interest include major and minor congenital malformations, spontaneous abortion, stillbirth, and infant developmental deficiencies. Data will be gathered through medical records and reported by healthcare providers at various stages of pregnancy and the infant's first year of life.
Who should consider this trial
Good fit: Ideal candidates include women of any age who are currently or recently pregnant and have consented to participate in the registry.
Not a fit: Patients who have been exposed to known teratogens or investigational medications during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of relugolix therapy during pregnancy, potentially guiding treatment decisions for pregnant women.
How similar studies have performed: While this study is observational and focuses on a specific therapy, similar observational studies have provided valuable safety data in pregnancy, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Wilmington, North Carolina
- Ppd — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials at Myovant
- Email: ClinicalTrials@Myovant.com
- Phone: 650-278-8743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.