ACTIVE_NOT_RECRUITING

Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating GATT

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

Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.

Official Title

The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation

Quick Facts

Study Start:2024-02-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06230770

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:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking currently have a uterus and ovaries
  2. * desire to initiate GATT
  3. * potential desire to initiate a progestin (within 14 days of GATT initiation)
  1. * previous gender-affirming surgery to remove their uterus and/or ovaries

Contacts and Locations

Principal Investigator

Kelsey Loeliger, MD. PhD
STUDY_DIRECTOR
UC San Diego
Sarah Averbach, MD, MSc
PRINCIPAL_INVESTIGATOR
UC San Diego

Study Locations (Sites)

University of California San Diego
San Diego, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Kelsey Loeliger, MD. PhD, STUDY_DIRECTOR, UC San Diego
  • Sarah Averbach, MD, MSc, PRINCIPAL_INVESTIGATOR, UC San Diego

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 Date2024-02-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • progestin
  • testosterone
  • gender-affirming
  • bleeding

Additional Relevant MeSH Terms

  • Gender
  • Contraception