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Progesterone in Gender Affirming Hormone Therapy Study

NCT06807580 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-24

No results posted yet for this study

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

Interventions

DRUG

Placebo

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

DRUG

Progesterone

Oral micronized progesterone 200 mg

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Vin Tangpricha, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06807580 on ClinicalTrials.gov