RECRUITING

Progesterone in Gender Affirming Hormone Therapy Study

Conditions

Transgender Women Gender affirming hormone therapy Progesterone

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06807580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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 * Current or recent (in the past 6 months) cannabis use * 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 (100-200 pg/mL) * Heavy smoking, defined as 25+ cigarettes per day * Non-English speaking or those with limited English proficiency

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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
* Current or recent (in the past 6 months) cannabis use
* 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 (100-200 pg/mL)
* Heavy smoking, defined as 25+ cigarettes per day
* Non-English speaking or those with limited English proficiency

Contacts and Locations

Study Contact

Vin Tangpricha, MD, PhD

CONTACT

404-727-7254

vin.tangpricha@emory.edu

Kayla Tanya Patel, MD

CONTACT

Principal Investigator

Vin Tangpricha, MD, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory Transgender Clinic

Atlanta, Georgia, 30308

United States

Collaborators and Investigators

Sponsor: Emory University

Vin Tangpricha, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2027-02

Study Record Updates

Study Start Date2025-03

Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

Gender affirming hormone therapy
Transgender women
Progesterone

Additional Relevant MeSH Terms

Transgender Women