🏛️ Verified NIH Record • Updated 2025-08-14

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring (NCT05739123)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Sumitomo Pharma Switzerland GmbH

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (4 items).

Location: PPD — Wilmington, North Carolina

Age range: 0 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • PPD — Wilmington, North Carolina

📞 Contact the Study Coordinator

Phone: (650) 278-8743

Email: ClinicalTrials@Myovant.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗