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Comparison · NCT04370548-012a3bbd

Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14

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. Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14. Trial comparisons, record NCT04370548-012a3bbd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04370548-012a3bbd

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.410.3270.499wilson
Risk in group 20.03390.009350.115wilson
Risk difference, group 1 minus group 20.3760.2590.468newcombe hybrid score
Risk ratio, group 1 over group 212.13.0548log
Odds ratio, group 1 over group 219.84.6284.8log
Number needed to treat, for one more participant with the outcome on Clindamycin Phosphate Vaginal Gel, 2% than on Placebo Vaginal Gel (Universal HEC Placebo Gel)2.662.143.85from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Clindamycin 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.50122OG000
Group 2Placebo 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.259OG001

Outcome

Type
SECONDARY
Title
Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14
Description
Time frame
Visit 2, Days 7-14 post randomization
Population
mITT population

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

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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