Clinical trial
An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice every 84 days
Overall objective: to investigate the clinical efficacy and safety of the new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice in every 84 days. Primary objective: to demonstrate that AMW Leuprorelin 10.72 mg implant leads to a consistent suppression of testosterone levels below castrate level (0.5 ng/mL).
Category | Value |
---|---|
Study start date | 2012-02-06 |