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

NCT06230770 | Active Not Recruiting

• 1 other identifier: 809057
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gender; Contraception

Keywords

progestin; testosterone; gender-affirming; bleeding

Outcome Measures

Primary Outcomes (1)

• Mean days bleeding or spotting

  mean number of days of bleeding or spotting during the 30 days after GATT initiation

  Start of GATT to 30 days

Interventions

Bleeding data BEHAVIORAL

Participants will report their daily bleeding patterns

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll 160 participants who are English-speaking, at least 18 years old, currently have a uterus and ovaries, desire to initiate GATT, and potentially desire to initiate a progestin (within 14 days of GATT initiation). To ensure generalizability of results, participants with baseline irregular bleeding will not be excluded. Participants who have recently initiated a progestin may be eligible for inclusion. Participants who have had gender-affirming surgery to remove their uterus and/or ovaries will not be eligible for inclusion. We will recruit participants from clinics in San Diego that prescribe GATT, including the UCSD OBGYN clinic, two UCSD Gender Health program affiliated clinics, and UCSD Student Health Services.

You may qualify if:

• English-speaking currently have a uterus and ovaries
• desire to initiate GATT
• potential desire to initiate a progestin (within 14 days of GATT initiation)

You may not qualify if:

• previous gender-affirming surgery to remove their uterus and/or ovaries

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Coitus; Hemorrhage

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kelsey Loeliger, MD. PhD

  UC San Diego

  STUDY DIRECTOR

• Sarah Averbach, MD, MSc

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: June 10, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)