Trial · NCT01832480
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
NCT01832480, Phase 3, Completed, Tulane University Health Sciences Center; results first posted 2019-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trichomonas Vaginalis Repeat Infections Among HIV Negative Women. Trials, record NCT01832480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01832480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
- NCT number
- NCT01832480
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 623 participants, actual
- Lead sponsor
- Tulane University Health Sciences Center
- Conditions
- Vaginitis Trichomonal or Due to Trichomonas
- Interventions
- MTZ 500 mg twice daily x 7 days, MTZ 2 g
- First posted
- 2013-04-16
- Last updated
- 2019-02-12
- Results first posted
- 2019-02-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | 4 weeks post treatment completion | Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | 4 weeks post treatment completion | 570 cases available. Multiple imputation performed for those with missing Test of Cure (TOC) data. | Participants | COUNT_OF_PARTICIPANTS |
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 Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | Trichomonas (TV) Positive After 2 g Dose | 58 | Participants | ||
| Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | Trichomonas (TV) Positive After Metronidazole (MTZ) Multi Dose | 34 | 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 (MTZ) 2 g | 311 | |
| Overall Study | STARTED | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days | 312 | |
| Overall Study | COMPLETED | Metronidazole (MTZ) 2 g | 270 | |
| Overall Study | COMPLETED | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days | 270 | |
| Overall Study | NOT COMPLETED | Metronidazole (MTZ) 2 g | 41 | |
| Overall Study | NOT COMPLETED | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days | 42 |
Source ClinicalTrials.gov
Adverse events60
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 | nausea | Gastrointestinal disorders | Metronidazole (MTZ) 2 g | 61 | 311 | 61 |
| other | nausea | Gastrointestinal disorders | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 63 | 312 | 63 |
| other | headache | Nervous system disorders | Metronidazole (MTZ) 2 g | 15 | 311 | 15 |
| other | headache | Nervous system disorders | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 24 | 312 | 24 |
| other | Vomiting | Gastrointestinal disorders | Metronidazole (MTZ) 2 g | 7 | 311 | 7 |
| other | Vomiting | Gastrointestinal disorders | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 13 | 312 | 13 |
| other | Dizziness | Nervous system disorders | Metronidazole (MTZ) 2 g | 18 | 311 | 18 |
| other | Dizziness | Nervous system disorders | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 16 | 312 | 16 |
| other | Bad taste in mouth | General disorders | Metronidazole (MTZ) 2 g | 6 | 311 | 6 |
| other | Bad taste in mouth | General disorders | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 4 | 312 | 4 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metronidazole (MTZ) 2 g | 0 | 311 |
| Total, all-cause mortality | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 0 | 312 |
| Total, other adverse events | Metronidazole (MTZ) 2 g | 90 | 311 |
| Total, other adverse events | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 89 | 312 |
| Total, serious adverse events | Metronidazole (MTZ) 2 g | 0 | 311 |
| Total, serious adverse events | Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose | 2 | 312 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
Trichomonas (TV) Positive After 2 g Dose vs Trichomonas (TV) Positive After Metronidazole (MTZ) Multi Dose: Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) | Trial comparisons |
| Metronidazole (MTZ) 2 g vs Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose: deaths from any cause | Trial comparisons |
| Metronidazole (MTZ) 2 g vs Metronidazole (MTZ) 500 mg Twice Daily x 7 Days Dose: 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/NCT01832480
GET https://conductscience.org/api/trials/v1/NCT01832480/events?page=2