Comparison · NCT03518034-6ae5fbf3
AndroGel 1.62% vs Placebo: Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. AndroGel 1.62% vs Placebo: Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event. Trial comparisons, record NCT03518034-6ae5fbf3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03518034-6ae5fbf3
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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 | 0.035 | 0.0286 | 0.0428 | wilson | |
| Risk in group 2 | 0.0246 | 0.0193 | 0.0313 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0104 | 0.00114 | 0.0198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 1.04 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 1.04 | 1.99 | log | |
| Number needed to treat, for one more participant with the outcome on AndroGel 1.62% than on Placebo | 96.2 | 50.5 | 876 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AndroGel 1.62% | Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary. | 91 | 2,601 | OG000 |
| Group 2 | Placebo | Participants received matching placebo OD. | 64 | 2,603 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event
- Description
Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.
- Time frame
- Randomization to event or last known date if no event (up to approximately 52 months).
- Population
- TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
- NCT number
- NCT03518034
- Phases
- PHASE4
- Conditions
- Hypogonadism, Cardiovascular Diseases
- Interventions
- AndroGel®, Placebo
- Lead sponsor
- AbbVie
- Results first posted
- 2024-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03518034?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.govNone 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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