Progesterone in Gender Affirming Hormone Therapy Study

Description

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.

Conditions

Transgender Women

Study Overview

Study Details

Study overview

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.

Effects of Oral Progesterone in Transgender Women on Breast Development, Sleep Quality, Psychological Distress, and Cardiovascular Risk

Progesterone in Gender Affirming Hormone Therapy Study

Condition
Transgender Women
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory Transgender Clinic, Atlanta, Georgia, United States, 30308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 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 (100-200 pg/mL)
  • * Heavy smoking, defined as 25+ cigarettes per day
  • * Non-English speaking or those with limited English proficiency

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Emory University,

Vin Tangpricha, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2027-02