Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01816295 | A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy | PHASE3 | COMPLETED | 715 | — | — | May 1, 2013 | Apr 1, 2015 | Dec 28, 2015 | 85 | United States, Argentina +7 |
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
| Arm | Type | Description |
|---|---|---|
| Placebo Solution | PLACEBO_COMPARATOR | Placebo Solution applied topically once daily for 12 weeks. |
| Testosterone Solution | EXPERIMENTAL | Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Testosterone Solution | DRUG | Administered topically to axillae. |
| Placebo Solution | DRUG | Administered topically to axillae. |
Inclusion Criteria: * Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits * At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive * Prostate Specific Antigen (PSA) \<4...