Phase
Condition
N/ATreatment
Progesterone
Placebo
Clinical Study ID
Ages 18-60 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants will be transgender women, who have been on gender-affirming hormonetherapy for at least 6 months before the start of the study.
Exclusion
Exclusion Criteria:
Peanut allergy
Liver disease (liver enzyme elevations and/or evidence of acute or chronichepatitis). 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 orrecent 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 GenderAffirming Hormone Therapy 9 Version #4, 10/30/24
Current or recent (in the past 6 months) cannabis use
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 estrogenfor 5 or more years OR positive family history of breast cancer) with results ofBIRADS 3 or higher. Subjects with a BIRADS 0 mammogram must have undergoneadditional imaging demonstrating BIRADS 1 or 2 prior to enrollment.
Have had or are planning to undergo breast enhancement or gender affirming topsurgery in the next 6 months
Uncontrolled hypertension, defined as systolic blood pressure ≥ 140 mm Hg and/ordiastolic 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 (100-200 pg/mL)
Heavy smoking, defined as 25+ cigarettes per day
Non-English speaking or those with limited English proficiency
Study Design
Study Description
Connect with a study center
Emory Transgender Clinic
Atlanta, Georgia 30308
United StatesActive - Recruiting
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