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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01248416 | Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature | PHASE3 | COMPLETED | 76 | — | — | Nov 1, 2010 | Sep 1, 2016 | Aug 7, 2018 | 4 | United States, Chile |
Differences in height gains
Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)
| Arm | Type | Description |
|---|---|---|
| Aromatase Inhibitor | ACTIVE_COMPARATOR | Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years |
| Growth Hormone | ACTIVE_COMPARATOR | Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years |
| Aromatase Inhibitor and Growth Hormone | ACTIVE_COMPARATOR | Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years |
| Name | Type | Description |
|---|---|---|
| Aromatase Inhibitor | DRUG | - |
| Growth Hormone | DRUG | - |
| Aromatase Inhibitor and Growth Hormone | DRUG | - |
Inclusion Criteria: * Males: Ages: 12 - less than 18 years. * Bone age less than 14 ½ years at study initiation. * Presence of puberty. * Idiopathic short stature will be defined as a short child equal or less than -2SD for height, with normal GH responses to stimuli (\> or = 5ng/ml to at least 2 s...