This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3
clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate
for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects
with advanced adenocarcinoma of the prostate.
Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria
will be enrolled. The IP will be given as a monthly dose for two cycles on day 0 and day 28.
The pharmacokinetic analysis will be done for 12 patients receiving Luprodex. The primary and
secondary outcomes will be captured on days as per protocol. Adverse events will be noted for
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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