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

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Sumitomo Pharma Switzerland GmbH
Study ID
NCT05739123
Status
Recruiting
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Conditions

  • Pregnancy Complications
  • Pregnancy Related
  • Pregnancy, High Risk

Eligibility Criteria

Sex
FEMALE
Age
0 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
Aug 2025
Primary completion
May 31, 2033
Completion
May 31, 2033

Study Design

Enrollment
728 participants (estimated)

Arms

  • Arm: Exposed Cohort
    Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy
  • Arm: Unexposed Cohort
    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 Outcome Measure

Major Congenital Malformation (MCM) [ Time Frame: Up to 10 years ]

Central Contacts

  • Clinical Trials at Myovant
    650-278-8743
    [email protected]
  • Myovant Medical Monitor Study Director

Locations (1)

FacilityCityStateZIPSite coordinators
PPDWilmingtonNorth Carolina28401
Ronna L Chan, PH.D., M.P.H.
919-270-6678
Ronna L Chan, PH.D, M.P.H. (PRINCIPAL_INVESTIGATOR)

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PPD· Wilmington, NC

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