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NCT05753813 · ClinicalTrials.gov registry record · Early Phase 1
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
A Early Phase 1 study of Bacterial Vaginosis and Vulvovaginal Candidiasis, sponsored by Queen's Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05753813 is a Early Phase 1 study of Bacterial Vaginosis and Vulvovaginal Candidiasis that is actively recruiting participants, run by Queen's Medical Center. The registered enrollment target is 22 participants, below the 337-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05753813, a Early Phase 1 study of Bacterial Vaginosis and Vulvovaginal Candidiasis, is actively recruiting participants, sponsored by Queen's Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.
Conditions Studied
Interventions
- DRUG Phexxi
Study Locations (1)
Hawaii
- Queens Medical Center, 1004 Clinic POB1 - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2026-12-30 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05753813
The ClinicalTrials.gov registry entry for NCT05753813 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 337-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (93% lower). The listed sponsor is Queen's Medical Center, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bacterial Vaginosis appearing as the primary indexed condition, and to 1 intervention - of which Phexxi is the first listed.
NCT05753813 reports 1 study location spanning 1 distinct geographic area - top geographies include Hawaii.
Frequently Asked Questions
What is clinical trial NCT05753813 about?
NCT05753813 is a clinical study titled "Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome". This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in th...
What is the current status of trial NCT05753813?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2023-12-15. Estimated completion is 2026-12-30.
What conditions does trial NCT05753813 study?
This clinical trial studies the following conditions: Bacterial Vaginosis, Vulvovaginal Candidiasis.
What interventions are being tested in trial NCT05753813?
The interventions under investigation include: Phexxi (DRUG).
Who is sponsoring clinical trial NCT05753813?
This trial is sponsored by Queen's Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05753813 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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