Comparison · NCT02232425-11bf348c
Drug: IX-01 vs Placebo: Incidence of Treatment-emergent 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. Drug: IX-01 vs Placebo: Incidence of Treatment-emergent Adverse Events. Trial comparisons, record NCT02232425-11bf348c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02232425-11bf348c
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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 | 0.214 | 0.127 | 0.338 | wilson | |
| Risk in group 2 | 0.3 | 0.167 | 0.479 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0857 | -0.285 | 0.0963 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.714 | 0.34 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 0.636 | 0.232 | 1.74 | log | |
| Number needed to treat, for one fewer participant with the outcome on Drug: IX-01 than on Placebo | 11.7 | 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 | Drug: IX-01 | Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity~IX-01 | 12 | 56 | OG000 |
| Group 2 | Placebo | Two to four capsules administered orally, 1-6 hours prior to sexual activity~Placebo | 9 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Incidence of Treatment-emergent Adverse Events
- Description
- Number of participants with at least one treatment-emergent adverse event
- Time frame
- Start of Treatment to end of study (approximately 10 weeks)
- Population
- Intent to treat, excluding outliers
Source ClinicalTrials.gov
Trial
- Title
- IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
- NCT number
- NCT02232425
- Phases
- PHASE2
- Conditions
- Premature Ejaculation
- Interventions
- IX-01, Placebo
- Lead sponsor
- Ixchelsis Limited
- Results first posted
- 2019-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02232425?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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