Comparison · NCT01230814-sae
Arm 1: Metronidazole Plus Miconazole vs Arm 2: Placebo: serious adverse events
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. Arm 1: Metronidazole Plus Miconazole vs Arm 2: Placebo: serious adverse events. Trial comparisons, record NCT01230814-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01230814-sae
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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 | 0.0259 | 0.00883 | 0.0733 | wilson | |
| Risk in group 2 | 0.00862 | 0.00152 | 0.0472 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0172 | -0.0249 | 0.0652 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.317 | 28.4 | log | |
| Odds ratio, group 1 over group 2 | 3.05 | 0.313 | 29.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm 1: Metronidazole Plus Miconazole than on Arm 2: Placebo | 58 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm 1: Metronidazole Plus Miconazole | Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month. | 3 | 116 | EG000 |
| Group 2 | Arm 2: Placebo | Placebo suppositories nightly for five consecutive nights each month. | 1 | 116 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Source ClinicalTrials.gov
Trial
- Title
- Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
- NCT number
- NCT01230814
- Phases
- PHASE2
- Conditions
- Bacterial Vaginosis, Candidiasis, Trichomoniasis
- Interventions
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate), Placebo
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2014-09-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01230814?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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