Trial · NCT02209519
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
NCT02209519, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2020-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Trial of Treatment of Male Partners of Women With BV. Trials, record NCT02209519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02209519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Controlled Trial of Treatment of Male Partners of Women With BV
- NCT number
- NCT02209519
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Recurrent Bacterial Vaginosis
- Interventions
- Metronidazole (male partner), Placeob (male partner)
- First posted
- 2014-08-06
- Last updated
- 2020-04-27
- Results first posted
- 2020-04-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female | 16 weeks post start of receipt of study drug | the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH \> 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score \>3 No Recurrence/Persistence is measured by: \- Presence of 0 -2 Amsel criteria; Nugent score 0-3. |
| Secondary | Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole | from the end of week 1 up to 16 weeks | time to recurrence measured in days |
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 | Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female | 16 weeks post start of receipt of study drug | those completing the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole | from the end of week 1 up to 16 weeks | unable to collect data due to lab issues |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female | Metronidazole | 87 | Participants | ||
| Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female | Placebo | 86 | 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 | Metronidazole | 107 | |
| Overall Study | STARTED | Placebo | 107 | |
| Overall Study | COMPLETED | Metronidazole | 107 | |
| Overall Study | COMPLETED | Placebo | 107 | |
| Overall Study | NOT COMPLETED | Metronidazole | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
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 |
|---|---|---|---|---|---|---|
| other | Infections and infestations | Infections and infestations | Metronidazole | 18 | 107 | 18 |
| other | Infections and infestations | Infections and infestations | Placebo | 21 | 107 | 21 |
| other | Injury | Injury, poisoning and procedural complications | Metronidazole | 0 | 107 | 0 |
| other | Injury | Injury, poisoning and procedural complications | Placebo | 1 | 107 | 1 |
| other | musculoskelatal | Musculoskeletal and connective tissue disorders | Metronidazole | 1 | 107 | 1 |
| other | musculoskelatal | Musculoskeletal and connective tissue disorders | Placebo | 0 | 107 | 0 |
| other | nervous | Nervous system disorders | Metronidazole | 1 | 107 | 1 |
| other | nervous | Nervous system disorders | Placebo | 3 | 107 | 3 |
| other | psychiatric | Psychiatric disorders | Metronidazole | 1 | 107 | 1 |
| other | psychiatric | Psychiatric disorders | Placebo | 0 | 107 | 0 |
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 | Metronidazole | 0 | 107 |
| Total, all-cause mortality | Placebo | 0 | 107 |
| Total, other adverse events | Metronidazole | 29 | 107 |
| Total, other adverse events | Placebo | 31 | 107 |
| Total, serious adverse events | Metronidazole | 0 | 107 |
| Total, serious adverse events | Placebo | 1 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33383580 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metronidazole vs Placebo: Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female | Trial comparisons |
| Metronidazole vs Placebo: deaths from any cause | Trial comparisons |
| Metronidazole vs Placebo: serious adverse events | 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/NCT02209519
GET https://conductscience.org/api/trials/v1/NCT02209519/registered