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

NCT ID: NCT06230770

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gender Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bleeding data

Participants will report their daily bleeding patterns

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Sarah Averbach, MD MAS

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelsey Loeliger, MD. PhD

Role: STUDY_DIRECTOR

UC San Diego

Sarah Averbach, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

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University of California San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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809057

Identifier Type: -

Identifier Source: org_study_id

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