GTX COMPLETES PATIENT ENROLLMENT OF ADT TRIAL
GTx has attained its enrollment goal in its pivotal Phase III clinical trial for the use of Acapodene (toremifene citrate) for the treatment of the serious side-effects of androgen deprivation therapy (ADT) for men with advanced prostate cancer.
Patients in the randomized, double-blind ADT study will receive either an 80 mg tablet of toremifene citrate or placebo, once a day, for two years. The primary endpoint of the trial is the occurrence of lumbar vertebral fractures. Secondary endpoints include hot flashes, gynecomastia, improvement in lipid profiles, and bone mineral density.