Observational study on the safety of relugolix therapy in pregnant women
Official title: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Run by Sumitomo Pharma Switzerland GmbH · NCT05739123 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Years and up |
| Sex | Women only |
| Enrollment | 728 (estimated) |
| Sponsor | Sumitomo Pharma Switzerland GmbH Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Status | Recruiting |
| Started | May 8, 2023 |
| Main results expected | May 2033 |
| Study ends | May 2033 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT05739123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women of any age who are currently or recently pregnant and have consented to participate in the registry.
✕Probably not a fit
Patients who have been exposed to known teratogens or investigational medications during pregnancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Ppd
Wilmington, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Clinical Trials at Myovant
- Email: ClinicalTrials@Myovant.com
- Phone: 650-278-8743
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.