Phase 3
Completed N=274
Testosterone Treatment for Hypogonadal Men
Source: ClinicalTrials.gov NCT00433199 ↗Enrolled (actual)
274
Serious AEs
2.2%
Results posted
Dec 2011
Primary outcomePrimary: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 — 81.6; 37.0 Percentage of subjects
Summary
Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 |
81.6; 37.0 | — |
| SECONDARY Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14 |
65.7; 29.7 | — |
| SECONDARY Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 |
82.5; 34.4 | — |
| SECONDARY Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 |
82.2; 28.6 | — |
| SECONDARY Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. |
78.4; 69.2; 77.0 | — |
| SECONDARY Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. |
77.9; 87.0; 79.2 | — |
Eligibility Criteria
Inclusion Criteria
- Low T males 18 - 80 years of age
Exclusion Criteria
- Normal T levels
- Elevated Prostatic Specific Antigen (PSA)
Data sourced from ClinicalTrials.gov (NCT00433199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.