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New treatment option for Transgender Women
Official title Progesterone in Gender Affirming Hormone Therapy Study
ClinicalTrials.gov ID: NCT06807580
What this study is testing
What is Progesterone?
Progesterone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for transgender women.
Also referred to as Prometrium 200mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, men only. Healthy volunteers may be eligible.
You may be able to join if
- \- Participants will be transgender women, who have been on gender-affirming hormone therapy for at least 6 months before the start of the study.
You likely can't join if
- 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...
- 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...
- Pre-existing cardiovascular disease
See the full eligibility 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.
- 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...
- 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. people with a BIRADS 0 mammogram...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.