Comparison · NCT01577537-aa8bb4be
VivaGel vs HEC Placebo: Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
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. VivaGel vs HEC Placebo: Number of Women With Clinical Cure at the Test of Cure Visit (TOC). Trial comparisons, record NCT01577537-aa8bb4be. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01577537-aa8bb4be
On this page
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 | 0.283 | 0.21 | 0.37 | wilson | |
| Risk in group 2 | 0.282 | 0.208 | 0.37 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00128 | -0.113 | 0.115 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.67 | 1.51 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.572 | 1.77 | log | |
| Number needed to treat, for one more participant with the outcome on VivaGel than on HEC Placebo | 780 | 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 | VivaGel | 1% SPL7013 Gel: Vaginal gel, daily for 7 days | 34 | 120 | OG000 |
| Group 2 | HEC Placebo | Placebo: Vaginal gel, daily for 7 days | 33 | 117 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
- Description
- Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
- Time frame
- Day 21-30
- Population
- mITT
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
- NCT number
- NCT01577537
- 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/NCT01577537?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01577537-aa8bb4be