Progesterone in Gender Affirming Hormone Therapy Study

NCT06807580 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY000061612025P011358
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Gender affirming hormone therapy; Transgender women; Progesterone

Outcome Measures

Primary Outcomes (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

  Baseline, Month 6

Secondary Outcomes (4)

• Effect of progesterone on breast development

  Baseline, Month 6

• Effect of progesterone on sleep quality

  Baseline, Month 6

• Effect of progesterone on gender congruence

  Baseline, Month 6

• Effect of progesterone on cardiovascular risk

  Baseline, Month 6

Study Arms (2)

Group A

PLACEBO COMPARATOR

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.

Drug: Placebo

Group B

EXPERIMENTAL

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.

Drug: Progesterone

Interventions

Placebo DRUG

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

Group A

Progesterone DRUG

Oral micronized progesterone 200 mg

Also known as: Prometrium 200mg

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Participants will be transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 may not qualify 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 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Transgender Clinic

Atlanta, Georgia, 30308, United States

RECRUITING

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Vin Tangpricha, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vin Tangpricha, MD, PhD

CONTACT

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

Kayla Tanya Patel, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)