Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABT-818, Lupron
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...
Leuprolide is used to treat central precocious puberty, a condition in which children begin puberty too early. It is given to suppress the hormonal signals that drive early sexual development. In this program it was studied in children aged 2 years and older with a diagnosis of precocious puberty.
Leuprolide is a gonadotropin-releasing hormone receptor (GNRHR) agonist. It binds to and activates GNRHR, initially stimulating then desensitizing the receptor, which reduces downstream release of luteinizing hormone and follicle-stimulating hormone. This suppression lowers sex steroid production and slows the progression of central precocious puberty.
Leuprolide is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott Laboratories sponsored the Phase 3 study of leuprolide 11.25 mg and 30 mg administered every three months for central precocious puberty.
Leuprolide is in Phase 3 development for central precocious puberty. The completed Phase 3 trial evaluated leuprolide 11.25 mg and 30 mg given every three months. It is an investigational use in this program and is not described as approved for this indication.
Leuprolide has been studied in one completed Phase 3 trial, NCT00635817, titled A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty. The trial enrolled 84 participants across the United States and Puerto Rico and was randomized and controlled.