Comparison · NCT02722278-sae
Oral Testosterone Undecanoate vs Axiron Testosterone Topical Solution: 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 vs Axiron Testosterone Topical Solution: serious adverse events. Trial comparisons, record NCT02722278-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02722278-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 | 0.012 | 0.00331 | 0.0429 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0653 | wilson | |
| Risk difference, group 1 minus group 2 | 0.012 | -0.0538 | 0.0429 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Oral Testosterone Undecanoate than on Axiron Testosterone Topical Solution | 83 | 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 | 166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).~Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL. | 2 | 166 | EG000 |
| Group 2 | Axiron Testosterone Topical Solution | 56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.~Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL. | 0 | 55 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 9 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
- NCT number
- NCT02722278
- Phases
- PHASE3
- Conditions
- Hypogonadism
- Interventions
- Oral Testosterone Undecanoate, Axiron Testosterone Topical Solution
- Lead sponsor
- Clarus Therapeutics, Inc.
- Results first posted
- 2018-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02722278?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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