Progesterone in Gender Affirming Hormone Therapy Study
Recruiting
Phase 2Interventional Study
Transgender Women
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 ou…
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
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