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NCT06470906 · ClinicalTrials.gov registry record · NA
Feasibility of an Oral Intervention for Sexual Health in Transgender Men
A NA study of Vaginal Dysbiosis and Vaginal Disease, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT06470906 is a NA study of Vaginal Dysbiosis and Vaginal Disease that has completed, run by Columbia University. The registered enrollment target is 29 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06470906, a NA study of Vaginal Dysbiosis and Vaginal Disease, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Transgender men (TGM) have a high incidence of sexually transmitted infected (STIs), including HIV, HPV and bacterial N. gonorrhea and C. trachomatis. In addition, TGM who start testosterone therapy (TT) experience significant vaginal morbidity that causes vaginal dryness and pain, due to the estrogen-inhibiting effects of TT on vaginal epithelium. Vaginal dysbiosis is a known contributor of increased STI risk and vaginal symptoms. In a future study, the investigators are planning a randomized trial of a 6-month oral Lactobacillus probiotics intervention in TGM on TT at the Callen-Lorde Community Health Center (CLCHC), New York City to determine whether this intervention can improve vaginal health in TGM on TT. In this study, the investigators will conduct a pilot and feasibility study to precede the main trial. The investigators will randomize 30 TGM on TT to receive either the intervention (consisting of Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001) or placebo (maltodextrin) for 4 weeks, evaluating the intervention's impact on vaginal microbiota and clinical outcomes, as well as its feasibility, acceptability, and adherence. This study will take place at the CLCHC Brooklyn site, aiming to gain pilot data, address feasibility and acceptability, and plan for the main trial accordingly.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo Group
- DIETARY_SUPPLEMENT Probiotic Group
Study Locations (1)
New York
- Callen-Lorde Community Health Center (CLCHC) - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2024-11-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06470906
The ClinicalTrials.gov registry entry for NCT06470906 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Vaginal Dysbiosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo Group is the first listed.
NCT06470906 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06470906 about?
NCT06470906 is a clinical study titled "Feasibility of an Oral Intervention for Sexual Health in Transgender Men". Transgender men (TGM) have a high incidence of sexually transmitted infected (STIs), including HIV, HPV and bacterial N. gonorrhea and C. trachomatis. In addition, TGM who start testosterone therapy (TT) experience significant vaginal morbidity that causes vaginal dryness and pain, due to the estrog...
What is the current status of trial NCT06470906?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2024-08-14. Estimated completion is 2024-11-21.
What conditions does trial NCT06470906 study?
This clinical trial studies the following conditions: Vaginal Dysbiosis, Vaginal Disease, Molecular-bacterial Vaginosis.
What interventions are being tested in trial NCT06470906?
The interventions under investigation include: Placebo Group (DIETARY_SUPPLEMENT), Probiotic Group (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06470906?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06470906 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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