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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00434824 | Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203) | PHASE2 | COMPLETED | 322 | — | — | Nov 1, 2001 | Jul 1, 2004 | Apr 16, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | Oral testosterone undecanoate (Andriol) |
| Arm 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Oral testosterone undecanoate (Andriol) | DRUG | treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses |
| Placebo | DRUG | treatment for 12 months with placebo in divided doses |
Inclusion Criteria: * Subjects were at least 50 years of age * A body mass index (BMI) between 18 and 34 kg/m\^2 * Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire) * Calculated free testosterone measurement of \<0.26 nmol/L in the ...