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

Description

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

Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pregnancy Related
Intervention / Treatment

-

Contacts and Locations

Wilmington

PPD, Wilmington, North Carolina, United States, 28401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Woman of any age
  • * Currently or recently pregnant
  • * Consent to participate
  • * Authorization for her HCP(s) to provide data to the registry
  • * Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
  • * 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
  • * 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

Ages Eligible for Study

0 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sumitomo Pharma Switzerland GmbH,

Study Record Dates

2033-05