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Also known as Leuprolide Acetate (LA), Leuprolide
Leuprolide/ML · 1 trial · 1 indication
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
| Arm | Type | Description |
|---|---|---|
| Leuprolide Acetate (LA) | EXPERIMENTAL | Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks. |
| Name | Type | Description |
|---|---|---|
| Leuprolide Acetate (LA) | DRUG | Administered intramuscularly as an injection |
Inclusion Criteria: * Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of ...
Leuprolide/ML is being developed for the treatment of central precocious puberty, a condition in which children begin puberty too early. It is an investigational formulation of leuprolide acetate studied specifically in pediatric patients with this endocrine disorder.
Leuprolide/ML acts as an agonist at the GNRHR, the gonadotropin-releasing hormone receptor. By binding this receptor, it modulates the hormonal signaling pathway that drives pubertal development, which is the mechanism explored for delaying premature puberty in children with central precocious puberty.
Leuprolide/ML is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this leuprolide acetate formulation in central precocious puberty.
Leuprolide/ML is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for central precocious puberty. The Phase 3 study evaluating this formulation has been completed.
Leuprolide/ML has been studied in one Phase 3 trial, NCT03695237, titled A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP). The trial enrolled 45 participants across the United States and Puerto Rico and is now completed.