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NCT00667368 · ClinicalTrials.gov registry record · Phase 3
Bacterial Vaginosis Home Screening to Prevent STDs
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,370
- Enrollment target
NCT00667368: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00667368 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,370 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667368, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,370 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV \[infection of the vagina\]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.
Primary Outcome
Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.
Interventions
- DRUG Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,370 participants |
| Start Date | 2008-07-28 |
| Est. Completion | 2014-12-31 |
| Phase | Phase 3 |
What the finished NCT00667368 record still lists
NCT00667368 is an interventional study that assigns participants to a tested intervention. Its 1,370 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 1 intervention - of which Metronidazole is the first listed.
NCT00667368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00667368 about?
NCT00667368 is a clinical study titled "Bacterial Vaginosis Home Screening to Prevent STDs". The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV \[infection of the vagina\]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonoco...
What is the current status of trial NCT00667368?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,370 participants. The study started on 2008-07-28. Estimated completion is 2014-12-31.
What interventions are being tested in trial NCT00667368?
The interventions under investigation include: Metronidazole (DRUG).
Who is sponsoring clinical trial NCT00667368?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00667368's enrollment target sits among peer trials
1,370 177th of 2000 higher than 1,822 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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