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NCT06807580 · ClinicalTrials.gov registry record · Phase 2
Progesterone in Gender Affirming Hormone Therapy Study
A Phase 2 study of Transgender Women, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06807580: Recruiting Phase 2 study of Transgender Women, sponsored by Emory University.
NCT06807580 is a Phase 2 study of Transgender Women that is actively recruiting participants, run by Emory University. The registered enrollment target is 40 participants, below the 68-participant average among 3 other Transgender Women trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06807580, a Phase 2 study of Transgender Women, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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: *
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Progesterone
Study Locations (1)
Georgia
- Emory Transgender Clinic - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-05-12 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What NCT06807580 shows while recruiting
NCT06807580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 68-participant average among 3 other Transgender Women trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Transgender Women appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06807580 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06807580 about?
NCT06807580 is a clinical study titled "Progesterone in Gender Affirming Hormone Therapy Study". 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.
What is the current status of trial NCT06807580?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-05-12. Estimated completion is 2027-02.
What conditions does trial NCT06807580 study?
This clinical trial studies the following conditions: Transgender Women.
What interventions are being tested in trial NCT06807580?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG).
Who is sponsoring clinical trial NCT06807580?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06807580 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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