Recruiting
Phase 2

Progesterone

Sponsor:

Emory University

Code:

NCT06807580

Conditions

Transgender Women

Eligibility Criteria

Sex: Male

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Placebo

Progesterone

Study Details

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.

Conditions

Transgender Women

Study ID

NCT06807580

Start date

May 12, 2025

Status verified date

Dec, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Group A

Group A will serve as our control group with participants on their existing gender-affirming therapy in addition to a placebo pill.

Laboratory assessments including estradiol, lipid profile, and Complete metabolic profile (CMP) will be performed at screening.

experimental: Group B

Group B will serve as our intervention group with participants on their existing gender-affirming therapy in combination with 200 mg oral micronized progesterone at bedtime.

Laboratory assessments including estradiol, lipid profile, and Complete metabolic profile (CMP) will be performed at screening.

Interventions

Placebo

The placebo will be nearly identical in size, color, and shape to micronized progesterone

Progesterone

Oral micronized progesterone 200 mg

Primary outcome measure

  • Psychological Distress [ Time Frame: Baseline, Month 6 ]

Central Contacts and Locations

Central contacts

Vin Tangpricha, MD, PhD

404-727-7254vin.tangpricha@emory.edu

Locations

Emory Transgender Clinic

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Vin Tangpricha, MD, PhD

404) 727-7254vin.tangpricha@emory.edu

More Information

Sponsor

Emory University

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Gender affirming hormone therapy
  • Transgender women
  • Progesterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.