Comparison · NCT00729469-sae
Subjects on Ospemifene 60 mg/Day vs Subjects on Placebo: serious adverse events
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. Subjects on Ospemifene 60 mg/Day vs Subjects on Placebo: serious adverse events. Trial comparisons, record NCT00729469-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00729469-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 | 0.013 | 0.00595 | 0.028 | wilson | |
| Risk in group 2 | 0.0154 | 0.00746 | 0.0313 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00239 | -0.0199 | 0.0146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.844 | 0.286 | 2.49 | log | |
| Odds ratio, group 1 over group 2 | 0.842 | 0.281 | 2.53 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Subjects on Ospemifene 60 mg/Day than on Subjects on Placebo | 418 | 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 | Subjects on Ospemifene 60 mg/Day | Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. | 6 | 463 | EG001 |
| Group 2 | Subjects on Placebo | Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. | 7 | 456 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
- NCT number
- NCT00729469
- Phases
- PHASE3
- Conditions
- Atrophy, Vaginal Diseases
- Interventions
- Ospemifene 60 mg, Placebo
- Lead sponsor
- Shionogi
- Results first posted
- 2013-06-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00729469?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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