ELIGARD® delivers powerful and sustained testosterone suppression that reflects current science.
One open-label, multicenter study was conducted with each ELIGARD formulation (7.5 mg, 22.5 mg, 30 mg, and 45 mg) in patients with Jewett stage A through D prostate cancer who were treated with at least a single injection of study drug. These studies evaluated the achievement and maintenance of castrate serum testosterone suppression over the duration of therapy.
Castrate levels in 2-4 weeks
Testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second or third week in the majority of patients. Castrate levels were generally reached within two to four weeks.
Castrate levels maintained
Castrate testosterone levels were maintained for the duration of the treatment with ELIGARD 7.5 mg. No increases above the castrate level occurred in any of the patients.
Castrate levels were maintained for the duration of treatment with ELIGARD 22.5 mg with only one patient demonstrating breakthrough following 1st injection; that patient remained at castrate levels following the second injection.
Once castrate levels were achieved with ELIGARD 30 mg, most (86/89) patients remained suppressed throughout the study.
Once castrate levels were achieved with ELIGARD 45 mg, only one patient (< 1%) experienced a breakthrough, with testosterone levels > 50 ng/dL.
Serum PSA decrease
Serum PSA decreased in all patients in all studies whose baseline values were elevated above the normal limit. 
A total of 91% to 95% of patients achieved normal serum PSA values at study conclusion. 
Response to ELIGARD should be monitored by periodic measurement of serum concentrations of testosterone and prostate specific antigen.
|Dose||7.5 mg||22.5 mg||30 mg||45 mg|
|Mean PSA reduction at study conclusion||94%||98%||86%||97%|
|Patients with normal PSA at study conclusion||94%||91%||93%||95%|
|In all studies, ELIGARD decreased serum PSA in all patients whose baseline values were elevated above normal. |
- ELIGARD® (leuprolide acetate) for injectable suspension, 7.5 mg, 22.5 mg, 30 mg, 45 mg prescribing information. Fort Collins, CO: Tolmar Therapeutics, Inc.; 2019