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NCT04531943 · ClinicalTrials.gov registry record
Feminizing Hormone Therapy and the Rectal Mucosa Immune Environment in Transgender Women
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 285
- Enrollment target
NCT04531943: Completed study, sponsored by Emory University.
NCT04531943 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 285 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04531943 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 285 participants
- Enrollment target
Study Summary
The overarching goal of this research study is to achieve a better understanding of the rectal mucosal effects of feminizing hormones in people assigned male sex at birth and currently taking feminizing hormones who have sex with men. Better understanding the rectal mucosa in this population will allow for the optimization of current biomedical HIV prevention interventions and enhance design of future interventions, including an effective HIV vaccine. This study will recruit approximately 520 transgender women who have receptive anal intercourse with men (TGWSM) and cis-gender men into one of two cohorts. Cohort 1 is a cross-sectional study and Cohort 2 is a longitudinal study; enrollment into each cohort is based on participant characteristics.
Primary Outcome
The median percentage of rectal mucosal CD4+ T cells that express CCR5 will be compared between groups in Cohort 1.
Interventions
- DRUG Estrogen
- DRUG Estrogen plus Progesterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2024-04-04 |
What the finished NCT04531943 record still lists
NCT04531943 is an observational study that tracks outcomes without assigning an intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Estrogen is the first listed.
NCT04531943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04531943 about?
NCT04531943 is a clinical study titled "Feminizing Hormone Therapy and the Rectal Mucosa Immune Environment in Transgender Women". The overarching goal of this research study is to achieve a better understanding of the rectal mucosal effects of feminizing hormones in people assigned male sex at birth and currently taking feminizing hormones who have sex with men. Better understanding the rectal mucosa in this population will al...
What is the current status of trial NCT04531943?
This trial is currently completed. The enrollment target is 285 participants. The study started on 2020-10-01. Estimated completion is 2024-04-04.
What interventions are being tested in trial NCT04531943?
The interventions under investigation include: Estrogen (DRUG), Estrogen plus Progesterone (DRUG).
Who is sponsoring clinical trial NCT04531943?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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