Comparison · NCT01577238-d1aef49f
VivaGel vs HEC Placebo: Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. VivaGel vs HEC Placebo: Number of Women With Clinical Cure at the End of Treatment Visit (EOT). Trial comparisons, record NCT01577238-d1aef49f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01577238-d1aef49f
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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 | 0.504 | 0.415 | 0.593 | wilson | |
| Risk in group 2 | 0.165 | 0.108 | 0.244 | wilson | |
| Risk difference, group 1 minus group 2 | 0.339 | 0.22 | 0.445 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.05 | 1.95 | 4.78 | log | |
| Odds ratio, group 1 over group 2 | 5.14 | 2.79 | 9.47 | log | |
| Number needed to treat, for one more participant with the outcome on VivaGel than on HEC Placebo | 2.95 | 2.25 | 4.54 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | VivaGel | 1% SPL7013 Gel: Vaginal gel, daily for 7 days | 59 | 117 | OG000 |
| Group 2 | HEC Placebo | Placebo: Vaginal gel, daily for 7 days | 19 | 115 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
- Description
- Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
- Time frame
- Day 9-12
- Population
- mITT
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
- NCT number
- NCT01577238
- Phases
- PHASE3
- Conditions
- Bacterial Vaginosis
- Interventions
- 1% SPL7013 Gel, Placebo
- Lead sponsor
- Starpharma Pty Ltd
- Results first posted
- 2019-07-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01577238?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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