Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03211156
The ClinicalTrials.gov registry entry for NCT03211156 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.