Comparison · NCT01534208-sae
Androxal 12.5 mg vs Androxal 25 mg: 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. Androxal 12.5 mg vs Androxal 25 mg: serious adverse events. Trial comparisons, record NCT01534208-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01534208-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 | 0.029 | 0.0134 | 0.0618 | wilson | |
| Risk in group 2 | 0.0318 | 0.0168 | 0.0593 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00282 | -0.0345 | 0.0332 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.911 | 0.33 | 2.52 | log | |
| Odds ratio, group 1 over group 2 | 0.909 | 0.318 | 2.59 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Androxal 12.5 mg than on Androxal 25 mg | 355 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Androxal 12.5 mg | Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated | 6 | 207 | EG000 |
| Group 2 | Androxal 25 mg | Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated | 9 | 283 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first administration of study drug until 8 weeks after end of treatment (8 months total)
Source ClinicalTrials.gov
Trial
- Title
- Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
- NCT number
- NCT01534208
- Phases
- PHASE3
- Conditions
- Secondary Hypogonadism
- Interventions
- Androxal
- Lead sponsor
- Repros Therapeutics Inc.
- Results first posted
- 2014-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01534208?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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