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Transgender WomenPhase 2NCT06807580

Progesterone in Gender Affirming Hormone Therapy Study

A Phase 2 study testing Progesterone in people with Transgender Women, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Transgender Women
What is being tested?
Progesterone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
12 May 2025to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants will be transgender women, who have been on gender-affirming hormone therapy for at least 6 months before the start of the study.

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vin Tangpricha, MD, PhD contact

404-727-7254

vin.tangpricha@emory.edu

Kayla Tanya Patel, MD contact

United States1 site, 1 recruiting

  • Emory Transgender Clinic

    Atlanta, Georgia, 30308

    Vin Tangpricha, MD, PhD, 404) 727-7254, vin.tangpricha@emory.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed 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, decreased testosterone, reduced HDL levels, and higher venous thromboembolism (VTE) risk. Cyproterone acetate, often studied in these contexts, is not FDA-approved in the U.S. due to hepatotoxicity, and its use in GAHT is rare. Limited research exists on micronized progesterone, the form most commonly prescribed.

A recent study on low-dose micronized progesterone found no significant effects on sleep quality, psychological distress, or breast development. To address research gaps, a new study aims to evaluate higher-dose micronized progesterone's impact on cardiovascular risk, sleep quality, breast development, and psychological distress over a longer period. The hypothesis suggests neutral effects on breast development, sleep, and quality of life, with potential negative to neutral cardiovascular effects.

Given the lack of recommendations for or against progesterone in GAHT, further research is critically needed.

Being tested
Placebo, Progesterone
Keywords
Gender affirming hormone therapy, Transgender women, Progesterone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • ProgesteroneDrug

    Also called Prometrium 200mg

    Oral micronized progesterone 200 mg

Study groups in NCT06807580
Study groupRoleWhat they receive
Group APlacebo comparatorGroup 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.
Receives: Drug: Placebo
Group BExperimentalGroup 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.
Receives: Drug: Progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological Distress

    Kessler Psychological Distress Scale (K10) scale will be used to measure distress.

    This is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period.

    The numbers attached to the patients 10 responses are added up and the total score is the score on the Kessler Psychological Distress Scale (K10). Scores will range from 10 to 50. People seen in primary care who:

    • score under 20 are likely to be well
    • score 20-24 are likely to have a mild mental disorder
    • score 25-29 are likely to have moderate mental disorder
    • score 30 and over are likely to have a severe mental disorder

    Measured: Baseline, Month 6

Secondary outcomes (4)

  1. Effect of progesterone on breast development

    Breast size will be measured using hemi-circumference. Hemi circumference will be measured as the medial breast infliction point, the most medial point of the breast across the nipple level to the lateral breast inflection point.

    Measured: Baseline, Month 6

  2. Effect of progesterone on sleep quality

    Sleep quality will be measured by having participants from both Group A and B take the 19 item Pittsburgh sleep index. The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire that assesses sleep quality and disturbances over the past month.

    Each item is scored on a scale of 0-3, with 3 being the worst. The global score ranges from 0-21, with higher scores indicating worse sleep quality.

    Measured: Baseline, Month 6

  3. Effect of progesterone on gender congruence

    The gender Congruence and Life Satisfaction Scale (GCLS) will be used. It is a 38-item scale with each item scored on a 5-point scale.

    Items are scored on a 5-point scale (always = 1; never = 5). A higher score indicates a more positive outcome (higher gender congruence, better gender-related mental well-being, and better general life satisfaction).

    Measured: Baseline, Month 6

  4. Effect of progesterone on cardiovascular risk

    Change in lipid profile from baseline.

    Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start12 May 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807580
Sponsor's protocol ID
STUDY00006161
Other IDs
2025P011358
Status last verified
Dec 2025
First submitted
29 Jan 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cromer DR, Diego DS, Luke T, Deppe E, Wu Z, O'Sullivan K, Kann RJ, Binongo JNG, Tangpricha V. Progesterone in feminizing gender affirming hormone therapy: study protocol for a randomized placebo-controlled trial. Contemp Clin Trials Commun. 2026 Sep 9;54:101683. doi: 10.1016/j.conctc.2026.101683. eCollection 2026 Dec.

    PubMed 42764919

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Progesterone in people with Transgender Women, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vin Tangpricha, MD, PhD (404-727-7254, vin.tangpricha@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological Distress (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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