Comparison · NCT01403116-sae
Oral Testosterone Undecanoate (TU) vs Topical Testosterone Gel: 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. Oral Testosterone Undecanoate (TU) vs Topical Testosterone Gel: serious adverse events. Trial comparisons, record NCT01403116-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01403116-sae
On this page
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 | 0.0683 | 0.0386 | 0.118 | wilson | |
| Risk in group 2 | 0.0375 | 0.0173 | 0.0794 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0308 | -0.0206 | 0.0846 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.82 | 0.69 | 4.81 | log | |
| Odds ratio, group 1 over group 2 | 1.88 | 0.679 | 5.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Oral Testosterone Undecanoate (TU) than on Topical Testosterone Gel | 32.4 | 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 | Oral Testosterone Undecanoate (TU) | Treatment Period 1: 100 mg capsules, BID, with food~Treatment Period 2: One of the following dosages:~* 100 mg BID~* 150 mg BID~* 100 mg BID~* 100 mg and 150 mg BID~* 150 mg capsules BID~Safety Follow-up Phase:~Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses~Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60. | 11 | 161 | EG000 |
| Group 2 | Topical Testosterone Gel | Treatment Period 1: 5 g of 1% transdermal T-gel applied QD~Treatment Period 2:~* 2.5 g of 1% transdermal T-gel applied QD~* 5 g of 1% transdermal T-gel applied QD~* 7.5 g of 1% transdermal T-gel applied QD~* 10 g of 1% transdermal T-gel applied QD~Safety Follow-up Phase:~Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses~topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60. | 6 | 160 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
- NCT number
- NCT01403116
- Phases
- PHASE3
- Conditions
- Male Hypogonadism
- Interventions
- Oral testosterone undecanoate, topical testosterone gel
- Lead sponsor
- Clarus Therapeutics, Inc.
- Results first posted
- 2018-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01403116?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01403116-sae