RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-08
Study Completion:2033-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05739123

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.

Ages Eligible for Study:0 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Woman of any age
  2. * Currently or recently pregnant
  3. * Consent to participate
  4. * Authorization for her HCP(s) to provide data to the registry
  5. * Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
  6. * 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
  1. * Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
  2. * Exposure to known teratogens and/or investigational medications during pregnancy
  3. * Lost to follow-up

Contacts and Locations

Study Contact

Clinical Trials at Myovant
CONTACT
650-278-8743
ClinicalTrials@Myovant.com
Myovant Medical Monitor Study Director
CONTACT

Study Locations (Sites)

PPD
Wilmington, North Carolina, 28401
United States

Collaborators and Investigators

Sponsor: Sumitomo Pharma Switzerland GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08
Study Completion Date2033-05

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2033-05

Terms related to this study

Keywords Provided by Researchers

  • Relugolix
  • Uterine Fibroids
  • Endometriosis
  • Pregnancy

Additional Relevant MeSH Terms

  • Pregnancy Related
  • Pregnancy Complications
  • Pregnancy, High Risk