Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
Other outcome measures included serum levels of LH, PSA, as well as non-clinical
assessments, eg, WHO Performance Status, pain level assessment, and quality of life
questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory
outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.
An extension period for the study included annual replacement of the implant until the
implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed
during the extension period.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
United States: Food and Drug Administration