Effects of Oral Progesterone in Transgender Women on Breast Development, Sleep Quality, Psychological Distress, and Cardiovascular Risk
Emory University
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.
Description
The transgender population in the U.S. has grown significantly, highlighting a lack of comprehensive research on the safety and efficacy of gender-affirming hormone therapy (GAHT). For transgender females, GAHT typically includes estrogen and an anti-androgen. Recently, there has been growing interest in adding progesterone, based on anecdotal reports of improved breast development and quality of life. However, progesterone's role in transgender women remains unclear. Studies have linked progesterone (mainly cyproterone acetate) to increased risks of meningiomas, elevated prolactin levels, de…
Eligibility
- Age range
- 18–60 years
- Sex
- Male
- Healthy volunteers
- Yes
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, hyperthyroid…
Interventions
- DrugPlacebo
The placebo will be nearly identical in size, color, and shape to micronized progesterone
- DrugProgesterone
Oral micronized progesterone 200 mg
Location
- Emory Transgender ClinicAtlanta, Georgia