Progesterone in Gender Affirming Hormone Therapy Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06807580
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Transgender Women

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    The placebo will be nearly identical in size, color, and shape to micronized progesterone
  • Progesterone — DRUG
    Oral micronized progesterone 200 mg

Study Details

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.

Key Dates

Start date
May 12, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group A
    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.
  • Experimental: Group B
    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.

Primary Outcome Measure

Psychological Distress [ Time Frame: Baseline, Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory Transgender ClinicAtlantaGeorgia30308
Vin Tangpricha, MD, PhD
[email protected]
404) 727-7254

Find similar trials in Atlanta, GA

By research site
Emory Transgender Clinic· Atlanta, GA

Related Studies