Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Leuprolide · 1 trial · 1 indication
Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone \>= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.
| Arm | Type | Description |
|---|---|---|
| Leuprolide acetate 11.25 mg | EXPERIMENTAL | There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B. |
| Leuprolide acetate 30 mg | EXPERIMENTAL | There are 2 arms that received leuprolide acetate 30 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm C and subjects who have previously been treated with leuprolide acetate are designated to be in Arm D. |
| Name | Type | Description |
|---|---|---|
| Leuprolide acetate 11.25 mg | DRUG | Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart. |
| Leuprolide acetate 30 mg | DRUG | Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart. |
Inclusion Criteria: * Subject has a clinical diagnosis of CPP. * Eligible to receive at least 6 mo of therapy to treat CPP after study entry. * Bone age advanced at least 1 year beyond the chronological age at time of diagnosis or first treatment. * In general good health with no uncontrolled, clin...