Comparison · NCT01845649-sae
WC3011 Estradiol Vaginal Cream (3 Times/Week) vs Vehicle (3 Times/Week): serious adverse events
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. WC3011 Estradiol Vaginal Cream (3 Times/Week) vs Vehicle (3 Times/Week): serious adverse events. Trial comparisons, record NCT01845649-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01845649-sae
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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 | 0.0108 | 0.00369 | 0.0314 | wilson | |
| Risk in group 2 | 0.00369 | 0.000652 | 0.0206 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00714 | -0.0112 | 0.0279 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.94 | 0.307 | 28 | log | |
| Odds ratio, group 1 over group 2 | 2.96 | 0.306 | 28.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on WC3011 Estradiol Vaginal Cream (3 Times/Week) than on Vehicle (3 Times/Week) | 140 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | WC3011 Estradiol Vaginal Cream (3 Times/Week) | WC3011 estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks. | 3 | 277 | EG001 |
| Group 2 | Vehicle (3 Times/Week) | Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks. | 1 | 271 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 12
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
- NCT number
- NCT01845649
- Phases
- PHASE3
- Conditions
- Vulvovaginal Atrophy
- Interventions
- WC3011 Estradiol Vaginal Cream, Vehicle
- Lead sponsor
- Warner Chilcott
- Results first posted
- 2022-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01845649?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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