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Also known as Leuprolide Acetate 3 Month Depot
Leuprolide 3 Month Depot · 1 trial · 12 indications
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.
| Arm | Type | Description |
|---|---|---|
| Leuprolide Acetate 3M Depot 11.25 mg | EXPERIMENTAL | Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart. |
| Leuprolide Acetate 3M Depot 30 mg | EXPERIMENTAL | Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. |
| Name | Type | Description |
|---|---|---|
| Leuprolide Acetate 3 Month Depot | DRUG | - |
Inclusion Criteria: * Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone \<4 mIU/mL at the Month 6 study visit of the lead-in study. * Demonstrated suppression ...
Leuprolide 3 Month Depot is a long-acting depot formulation of leuprolide acetate, a gonadotropin-releasing hormone (GnRH) agonist. It is being developed by AbbVie Inc. (ticker ABBV) for the treatment of central precocious puberty, a condition in which children begin puberty abnormally early. The depot is designed to release drug over a three-month period.
Leuprolide 3 Month Depot is used for the treatment of central precocious puberty, a pediatric condition in which puberty starts too early. It is a depot formulation given to suppress the hormonal drive behind early pubertal development. The program is in Phase 3 development and is not yet approved.
Leuprolide 3 Month Depot targets GNRHR, the gonadotropin-releasing hormone receptor, acting as an agonist. Continuous receptor stimulation desensitizes the pituitary and suppresses luteinizing hormone (LH) release, which is the intended effect in central precocious puberty. The trial tracked LH suppression and Tanner staging as key measures.
Leuprolide 3 Month Depot is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program for this depot formulation in central precocious puberty.
Leuprolide 3 Month Depot is in Phase 3 development. It is investigational and has not been approved. The Phase 3 program includes one completed trial, and no trials are currently listed as active.
Leuprolide 3 Month Depot has been studied in the Phase 3 trial NCT00667446, titled Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty. That trial is completed, enrolled 72 participants, used a controlled design, and was conducted in the United States and Puerto Rico.
Yes. Leuprolide 3 Month Depot is also known as Leuprolide Acetate 3 Month Depot. The two names refer to the same depot formulation of leuprolide acetate developed by AbbVie for central precocious puberty, so readers searching either name are looking at the same asset.