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Lupron · 1 trial · 1 indication
Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).
Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lupron (leuprolide acetate) | DRUG | Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP. |
Inclusion Criteria: * Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys. * Confirmation of diagnosis by a pubertal res...
Lupron is used for the treatment of central precocious puberty, a condition where puberty begins abnormally early. It is being studied in a Phase 3 clinical trial for this indication. The drug is being developed by Abbott Laboratories.
Lupron targets the gonadotropin-releasing hormone receptor, which plays a role in the release of sex hormones. By acting on this receptor, it helps manage the early onset of puberty in children with central precocious puberty.
Lupron is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug is currently in Phase 3 clinical development for the treatment of central precocious puberty.
Lupron is in Phase 3 clinical development. A Phase 3 trial, NCT00660010, has been completed for the treatment of central precocious puberty. The drug is investigational and not yet approved for this indication.
Lupron has one completed Phase 3 clinical trial, NCT00660010, titled 'Study of Lupron Depot In The Treatment of Central Precocious Puberty'. This trial enrolled 55 participants in the United States and was not randomized or double-blinded.
Yes, Lupron is also known as Lupron Depot. The clinical trial NCT00660010 specifically studied Lupron Depot in the treatment of central precocious puberty, indicating that Lupron and Lupron Depot refer to the same drug product.