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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06230770
Enrollment
160
Registered
2024-01-30
Start date
2024-02-01
Completion date
2026-12-31
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Gender

Keywords

progestin, testosterone, gender-affirming, bleeding

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.

Interventions

BEHAVIORALBleeding data

Participants will report their daily bleeding patterns

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean days bleeding or spottingStart of GATT to 30 daysmean number of days of bleeding or spotting during the 30 days after GATT initiation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026