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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: Completed NA study of Vaginal Dysbiosis and Vaginal Disease, sponsored by Columbia University.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators aim to determine the effect of the Lactobacillus-probiotic intervention on molecular-BV through assessing Lactobacillus and other bacteria in the participants vaginal microbiome at the end of the intervention in TGM on TT.
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 |
What the finished NCT06470906 record still lists
NCT06470906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06470906's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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