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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 ...