Placebo + Lifestyle Therapy vs Testosterone + Lifestyle Therapy: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0244 | 0.00432 | 0.126 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0238 | 0.00422 | 0.123 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000581 | -0.101 | 0.104 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.0663 | 15.8 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.062 | 17 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo + Lifestyle Therapy than on Testosterone + Lifestyle Therapy | 1,720 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Placebo + Lifestyle Therapy | Placebo in combination with behavioral diet to induce \~10% weight loss and supervised aerobic and exercise training~Lifestyle Therapy: Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week~Placebo: Placebo gel for testosterone | 1 | 41 | EG000 | ClinicalTrials.gov |
| Group 2 | Testosterone + Lifestyle Therapy | Testosterone replacement in combination with behavioral diet to induce \~10% weight loss + supervised aerobic and exercise training~Testosterone: Daily testosterone gel applied once daily in the morning to intact skin~Lifestyle Therapy: Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week | 1 | 42 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | 6 months | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Lifestyle Intervention and Testosterone Replacement in Obese Seniors | ClinicalTrials.gov |
| NCT number | NCT02367105 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Obesity and Hypogonadism | ClinicalTrials.gov |
| Interventions | Testosterone, Lifestyle Therapy, Placebo | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Results first posted | 2020-08-31 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02367105?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.