Actively Recruiting

Phase 2
Age: 18Years - 60Years
MALE
Healthy Volunteers
NCT06807580

Progesterone in Gender Affirming Hormone Therapy Study

Led by Emory University · Updated on 2025-12-24

40

Participants Needed

1

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Progesterone in Gender Affirming Hormone Therapy Study

Who Can Participate

Age: 18Years - 60Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be transgender women
  • Participants must have been on gender-affirming hormone therapy for at least 6 months before starting the study
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • Peanut allergy
  • Liver disease or elevated liver enzymes
  • Stage 4 or 5 chronic kidney disease
  • Congestive heart failure
  • Medical conditions or medications linked to gynecomastia
  • Existing cardiovascular disease
  • History of thromboembolism or clotting disorders
  • History of breast cancer
  • Prior progesterone use
  • Uncontrolled depression or suicidal thoughts
  • Current hypothyroidism
  • Cannabis use more than once a week in the past 3 months
  • Known BRCA 1 or 2 gene mutations or familial breast cancer
  • Abnormal mammogram results (BIRADS 3 or higher) if applicable
  • Planned or recent breast enhancement or gender affirming surgery within 6 months
  • Uncontrolled high blood pressure
  • Very high triglycerides (≥ 500 mg/dL)
  • Kidney function below threshold (eGFR < 30 mL/min/1.73m2)
  • Estradiol levels outside 100-300 pg/mL
  • Heavy smoking (25 or more cigarettes per day)
  • Non-English speaking or limited English proficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory Transgender Clinic

Atlanta, Georgia, United States, 30308

Actively Recruiting

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Research Team

V

Vin Tangpricha, MD, PhD

CONTACT

K

Kayla Tanya Patel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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