This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on prostate size and related lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH).
This clinical trial is designed as a randomized, placebo-controlled, multi-center phase 2 trial to evaluate the efficacy and safety of OPK-88004 in men with benign prostatic hyperplasia. Eligible subjects will be randomized into one of two OPK-88004 treatment groups or a placebo group after a 4-week screening period. Subjects will have monthly visits over a 16- week treatment period and will be evaluated for the effect of OPK-88004 on prostate volume and safety measures, as well as plasma levels of OPK-88004.