Effects of progestin contraception on bleeding in individuals starting testosterone therapy
The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation
University of California, San Diego · NCT06230770
This study looks at how using progestin contraception affects bleeding patterns and satisfaction in gender diverse individuals starting testosterone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06230770 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on gender diverse individuals who are initiating gender-affirming testosterone therapy (GATT) and may also choose to use progestins for contraception and to manage uterine bleeding. It aims to evaluate the bleeding patterns and patient satisfaction among those starting GATT with or without concurrent progestin use. By collecting and analyzing bleeding data, the study seeks to provide clinicians with better insights to counsel patients on the potential effects of progestin on their bleeding patterns. This research addresses a gap in knowledge regarding the experiences of individuals using GATT and progestins, which has been largely extrapolated from studies on cisgender women.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking individuals with a uterus and ovaries who wish to initiate GATT and may also want to start a progestin within 14 days of GATT initiation.
Not a fit: Patients who have previously undergone gender-affirming surgery to remove their uterus and/or ovaries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information to help clinicians better counsel patients on the effects of progestin use alongside testosterone therapy.
How similar studies have performed: While research on progestin use in cisgender women exists, this study is novel in its focus on gender diverse individuals using GATT, making it a unique contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Sarah Averbach, MD, MSc — UC San Diego
- Study coordinator: Marisa Hildebrand, MPH
- Email: mchildeb@health.ucsd.edu
- Phone: 8582243319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gender, Contraception, progestin, testosterone, gender-affirming, bleeding