Comparison · NCT04370548-deaths
Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): deaths from any cause
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. Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): deaths from any cause. Trial comparisons, record NCT04370548-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04370548-deaths
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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 | 0.00000000000000000173 | 0.0186 | wilson | |
| Risk in group 2 | 0 | 0 | 0.036 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.036 | 0.0186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Clindamycin Phosphate Vaginal Gel, 2% | One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization. | 0 | 203 | EG000 |
| Group 2 | Placebo Vaginal Gel (Universal HEC Placebo Gel) | One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization. | 0 | 103 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- Adverse Events were collected for the entire study duration, approximately 3.5 months.
Source ClinicalTrials.gov
Trial
- Title
- DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
- NCT number
- NCT04370548
- Phases
- PHASE3
- Conditions
- Bacterial Vaginosis
- Interventions
- DARE-BV1clindamycin phosphate vaginal gel, 2%
- Lead sponsor
- Daré Bioscience, Inc.
- Results first posted
- 2021-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04370548?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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