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NCT03211156 · ClinicalTrials.gov registry record · Phase 2
Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
A Phase 2 study of Vaginitis Gardnerella, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 2
- Study locations
NCT03211156: Completed Phase 2 study of Vaginitis Gardnerella, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03211156 is a Phase 2 study of Vaginitis Gardnerella that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03211156, a Phase 2 study of Vaginitis Gardnerella, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled Phase 2 study designed to determine if amoxicillin will eradicate vaginal colonization/infection with Gardnerella vaginalis (GV) when administered to women who are colonized/infected with GV but have no clinical evidence of Bacterial Vaginosis (BV). The study will be conducted at 2 clinics in the United States: University of Alabama at Birmingham and Wake Forest University Health Sciences. Entire study duration is approximately 24 months and subject participation duration is approximately 22 days. Approximately 245 healthy adult females, 18 to 45 years of age will be screened to enroll approximately 98 participants to achieve 82 evaluable participants at the test of cure (ToC) visit. Participants will be enrolled and randomized to one of two groups, either amoxicillin (2 x 250 mg capsules by mouth twice daily for 7 days) or placebo. Women who are enrolled will be asked to return for one further visit, Visit 2 (Day 15 - 21), where a ToC will be completed. For those not enrolled, participation will end at their post screening follow up phone call. Women will be asked to use condoms during their participation. The primary objective is to determine if treatment with amoxicillin eradicates GV in women who are colonized/infected with GV but have no clinical evidence of BV.
Primary Outcome
Eradication of GV is defined by a negative NAAT result for GV at Visit 2. Participants who have a missing GV NAAT result at the test of cure (TOC) visit were classified as treatment failures. The denominator for proportions is based on the number of subjects who were randomized to the specified treatment group.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Amoxicillin
Study Locations (2)
Alabama
- University of Alabama at Birmingham School of Medicine - Infectious Disease - Birmingham
North Carolina
- Guilford County Health Department - Greensboro - STD Clinic - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 2 |
What the finished NCT03211156 record still lists
NCT03211156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Vaginitis Gardnerella appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03211156 reports a single indexed study location in Alabama, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03211156 about?
NCT03211156 is a clinical study titled "Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin". This is a randomized, double-blind, placebo-controlled Phase 2 study designed to determine if amoxicillin will eradicate vaginal colonization/infection with Gardnerella vaginalis (GV) when administered to women who are colonized/infected with GV but have no clinical evidence of Bacterial Vaginosis (...
What is the current status of trial NCT03211156?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2017-09-11. Estimated completion is 2019-08-22.
What conditions does trial NCT03211156 study?
This clinical trial studies the following conditions: Vaginitis Gardnerella.
What interventions are being tested in trial NCT03211156?
The interventions under investigation include: Placebo (OTHER), Amoxicillin (DRUG).
Who is sponsoring clinical trial NCT03211156?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03211156 being conducted?
This trial has 2 study locations across Alabama, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03211156's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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