Effects of Progesterone on Transgender Women
Effects of Oral Progesterone in Transgender Women on Breast Development, Sleep Quality, Psychological Distress, and Cardiovascular Risk
This study is testing whether taking oral progesterone can help reduce psychological distress and improve other aspects of life for transgender women who have been on hormone therapy for at least six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06807580 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oral progesterone in transgender women who have been on gender-affirming hormone therapy for at least six months. The primary focus is to assess the impact of progesterone on psychological distress, while secondary outcomes include sleep quality, breast size, quality of life, gender congruence, and cardiovascular risk. Given the limited research on the role of progesterone in this population, the study aims to fill critical gaps in understanding its safety and efficacy. Participants will be randomly assigned to receive either progesterone or a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are transgender women who have been undergoing gender-affirming hormone therapy for at least six months.
Not a fit: Patients with a history of thromboembolism, liver disease, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the role of progesterone in improving the quality of life and health outcomes for transgender women.
How similar studies have performed: While previous studies on low-dose micronized progesterone have shown limited effects, this study aims to explore higher doses, making it a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Participants will be transgender women, who have been on gender-affirming hormone therapy for at least 6 months before the start of the study. Exclusion Criteria: * Peanut allergy * Liver disease (liver enzyme elevations and/or evidence of acute or chronic hepatitis). In our lab, the upper limit of normal for aspartate aminotransferase (AST) is 39, and the upper limit of normal for alanine aminotransferase (ALT) is 52. * Stage 4/5 chronic kidney disease * Congestive heart failure * Medical disease or medication use associated with gynecomastia (i.e tumor, hyperthyroidism, chronic kidney disease, cirrhosis, ACE inhibitors, statins, haloperidol, tricyclic antidepressants, atypical antipsychotics) * Pre-existing cardiovascular disease * Prior or current history of thromboembolism, known clotting disorders, current or recent anti-thrombotic therapy for venous thromboembolism. * History of breast cancer * Prior progesterone use * Uncontrolled depression and/or suicidal ideation * Current hypothyroidism (even if controlled with treatment) Progesterone in Gender Affirming Hormone Therapy 9 Version #4, 10/30/24 * Cannabis use of greater than 1 use/week in the past 3 months * Previously identified BRCA 1 or 2 gene mutation or other familial breast cancer. * Abnormal mammogram (if indicated - for patients above the age of 50 and on estrogen for 5 or more years OR positive family history of breast cancer) with results of BIRADS 3 or higher. Subjects with a BIRADS 0 mammogram must have undergone additional imaging demonstrating BIRADS 1 or 2 prior to enrollment. * Have had or are planning to undergo breast enhancement or gender affirming top surgery in the next 6 months * Uncontrolled hypertension, defined as systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mmHg. * Triglycerides ≥ 500 mg/dL. * In our lab, the upper limit of normal for aspartate aminotransferase (AST) is 39, and the upper limit of normal for alanine aminotransferase (ALT) is 52. * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2. * Estradiol levels outside the stable range (100-300 pg/mL) * Heavy smoking, defined as 25+ cigarettes per day * Non-English speaking or those with limited English proficiency
Where this trial is running
Atlanta, Georgia
- Emory Transgender Clinic — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Vin Tangpricha, MD, PhD — Emory University
- Study coordinator: Vin Tangpricha, MD, PhD
- Email: vin.tangpricha@emory.edu
- Phone: 404-727-7254
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.