Progesterone for Transgender Women

Overseen By Kayla Tanya Patel, MD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Emory University

Must be taking: Gender-affirming hormones

Must not be taking: ACE inhibitors, Statins, Antipsychotics, others

Disqualifiers: Liver disease, Kidney disease, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vin Tangpricha, MD, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for transgender women who are interested in the potential benefits of progesterone on psychological well-being, sleep, breast development, quality of life, and cardiovascular health.

Inclusion Criteria

I am a transgender woman and have been on hormone therapy for at least 6 months.

Exclusion Criteria

Peanut allergy

Non-English speaking or those with limited English proficiency

I have been diagnosed with congestive heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either a placebo or 200 mg oral micronized progesterone at bedtime in addition to their existing gender-affirming therapy

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Progesterone

Trial Overview The study tests Oral Progesterone against a placebo to see if it helps reduce psychological distress and improves sleep quality, breast size, overall quality of life and gender congruence without increasing cardiovascular risk.

Participant Groups

Group I: Group B Experimental Treatment 1 Intervention

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.

Group II: Group A Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+