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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00475501 | 5-Alpha Reductase and Anabolic Effects of Testosterone | PHASE2 | COMPLETED | 60 | — | — | Jan 1, 2007 | Oct 1, 2014 | Oct 11, 2018 | 1 | United States |
1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | testosterone enanthate |
| Arm 2 | EXPERIMENTAL | finasteride |
| Arm 3 | EXPERIMENTAL | testosterone enanthate + finasteride |
| Arm 4 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| Testosterone Enanthate | DRUG | 125 mg, i.m. injection, once/week, for 52 weeks |
| Finasteride | DRUG | 5 mg, oral, once/day, for 52 weeks |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Age \> 60 years males * Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida. * Consenting subjects who have a morning (between 6:00 AM and 10:00 AM) serum total testosterone 300 ng/dL or bioavailable testosterone concentration 70 ng/dL and no exclusio...