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

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University of California San Diego

Status

Enrolling

Conditions

Contraception
Gender

Treatments

Behavioral: Bleeding data

Study type

Observational

Funder types

Other

Identifiers

NCT06230770
809057

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Marisa Hildebrand, MPH; Kelsey Loeliger, MD, PhD

Data sourced from clinicaltrials.gov

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