Comparison · NCT02308033-bb53f562
Metronidazole Vaginal Gel vs Gel Vehicle: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Metronidazole Vaginal Gel vs Gel Vehicle: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit. Trial comparisons, record NCT02308033-bb53f562. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02308033-bb53f562
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.618 | 0.506 | 0.719 | wilson | |
| Risk in group 2 | 0.217 | 0.142 | 0.317 | wilson | |
| Risk difference, group 1 minus group 2 | 0.402 | 0.251 | 0.527 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.85 | 1.83 | 4.45 | log | |
| Odds ratio, group 1 over group 2 | 5.85 | 2.91 | 11.8 | log | |
| Number needed to treat, for one more participant with the outcome on Metronidazole Vaginal Gel than on Gel Vehicle | 2.49 | 1.9 | 3.98 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Metronidazole Vaginal Gel | One applicator full at bedtime~Metronidazole | 47 | 76 | OG000 |
| Group 2 | Gel Vehicle | One applicator full at bedtime~Gel vehicle | 18 | 83 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
- Description
The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine fishy odor, 3. the saline wet mount is \<20% clue cells
- Time frame
- 7-14 days after beginning treatment
- Population
- mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
Source ClinicalTrials.gov
Trial
- Title
- Multi-Center Study of New Medications to Treat Vaginal Infections
- NCT number
- NCT02308033
- Phases
- PHASE3
- Conditions
- Vaginal Infection
- Interventions
- Metronidazole, Gel vehicle
- Lead sponsor
- Curatek Pharmaceuticals, LLC
- Results first posted
- 2020-07-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02308033?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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