NCT06807580 Progesterone in Gender Affirming Hormone Therapy Study
| NCT ID | NCT06807580 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | Transgender Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-05-12 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to study the effects of Oral Progesterone in Transgender Women. The primary goal is to study the effect of progesterone on psychological distress and secondarily on sleep quality, breast size, quality of life and gender congruence and cardiovascular risk.
Eligibility 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
Contact & Investigator
Vin Tangpricha, MD, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT06807580 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 60 Years, studying Transgender Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06807580 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06807580 currently recruiting?
Yes, NCT06807580 is actively recruiting participants. Contact the research team at vin.tangpricha@emory.edu for enrollment information.
Where is the NCT06807580 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT06807580 clinical trial?
NCT06807580 is sponsored by Emory University. The principal investigator is Vin Tangpricha, MD, PhD at Emory University. The trial plans to enroll 40 participants.