Trial · NCT00667368
Bacterial Vaginosis Home Screening to Prevent STDs
NCT00667368, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2015-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bacterial Vaginosis Home Screening to Prevent STDs. Trials, record NCT00667368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667368
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bacterial Vaginosis Home Screening to Prevent STDs
- NCT number
- NCT00667368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,370 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Bacterial Vaginosis
- Interventions
- Metronidazole
- First posted
- 2008-04-28
- Last updated
- 2020-02-18
- Results first posted
- 2015-10-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment | At 4, 8, and 12 months after enrollment. | 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. |
| Secondary | Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months | 2, 4, 6, 8, 10, 12 months after enrollment | Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment | At 4, 8, and 12 months after enrollment. | Number infections per 100 person-years | NUMBER | |
| SECONDARY | Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months | 2, 4, 6, 8, 10, 12 months after enrollment | All randomized participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment | Control | 19.2 | 95% Confidence Interval 15.9 to 23.2 | Number infections per 100 person-years | |
One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment | Intervention | 18.3 | 95% Confidence Interval 15.1 to 22.1 | Number infections per 100 person-years | |
| Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months | Control | 92.5 | percentage of participants | ||
| Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months | Intervention | 82.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 682 | |
| Overall Study | STARTED | Intervention | 683 | |
| Overall Study | COMPLETED | Control | 482 | |
| Overall Study | COMPLETED | Intervention | 511 | |
| Overall Study | NOT COMPLETED | Control | 200 | |
| Overall Study | NOT COMPLETED | Intervention | 172 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Wound Infection | Infections and infestations | Control | 0 | 682 | 0 |
| serious | Wound Infection | Infections and infestations | Intervention | 1 | 683 | 1 |
| serious | Intervertebral Disk Protrusion | Musculoskeletal and connective tissue disorders | Control | 0 | 682 | 0 |
| serious | Intervertebral Disk Protrusion | Musculoskeletal and connective tissue disorders | Intervention | 1 | 683 | 1 |
| serious | Turbo-Ovarian Abscess | Reproductive system and breast disorders | Control | 0 | 682 | 0 |
| serious | Turbo-Ovarian Abscess | Reproductive system and breast disorders | Intervention | 1 | 683 | 1 |
| serious | Demyelination | Nervous system disorders | Control | 0 | 682 | 0 |
| serious | Demyelination | Nervous system disorders | Intervention | 1 | 683 | 1 |
| serious | Optic Neuritis | Nervous system disorders | Control | 0 | 682 | 0 |
| serious | Optic Neuritis | Nervous system disorders | Intervention | 1 | 683 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | Intervention | ||
| Total, other adverse events | Control | 0 | 682 |
| Total, other adverse events | Intervention | 0 | 683 |
| Total, serious adverse events | Control | 3 | 682 |
| Total, serious adverse events | Intervention | 7 | 683 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26611782 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intervention vs Control: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00667368
GET https://conductscience.org/api/trials/v1/NCT00667368/registered