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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230770
• Other study ID #: 809057
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Marisa Hildebrand, MPH
• Phone: 8582243319
• Email: mchildeb[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Contraception
• Gender
• Hemorrhage

Intervention

Behavioral:
• Bleeding data
Participants will report their daily bleeding patterns

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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