Comparison · NCT03935217-3bf58cd0
Solosec 2 Grams vs Placebo: Microbiological Cure at the TOC Visit
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. Solosec 2 Grams vs Placebo: Microbiological Cure at the TOC Visit. Trial comparisons, record NCT03935217-3bf58cd0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03935217-3bf58cd0
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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 | 0.922 | 0.83 | 0.966 | wilson | |
| Risk in group 2 | 0.0149 | 0.00264 | 0.0798 | wilson | |
| Risk difference, group 1 minus group 2 | 0.907 | 0.794 | 0.953 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 61.8 | 8.82 | 433 | log | |
| Odds ratio, group 1 over group 2 | 779 | 88.4 | 6,860 | log | |
| Number needed to treat, for one more participant with the outcome on Solosec 2 Grams than on Placebo | 1.1 | 1.05 | 1.26 | 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 | Solosec 2 Grams | Orally administered as a single dose with applesauce.~Secnidazole: Oral Granules containing secnidazole | 59 | 64 | OG000 |
| Group 2 | Placebo | Orally administered as a single dose with applesauce.~Secnidazole: Oral Granules containing secnidazole | 1 | 67 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Microbiological Cure at the TOC Visit
- Description
- Vaginal Culture negative for T. vaginalis at TOC Visit
- Time frame
- Study Day 6-12
- Population
- Modified Intent to Treat Population (Patients with culture positive for T. vaginalis at baseline)
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
- NCT number
- NCT03935217
- Phases
- PHASE3
- Conditions
- Trichomonas Infection
- Interventions
- Secnidazole, Placebo
- Lead sponsor
- Lupin Research Inc
- Results first posted
- 2023-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03935217?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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