Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of 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.

Inclusion Criteria:

- Male 45 yrs or older

- BPH diagnosis

- Lower urinary tract symptoms secondary to BPH

- Enlarged prostate

- Have not received prior treatment with 5-ARIs (finasteride, dutasteride)

Exclusion Criteria:

- Post void residual volume ≥200 mL

- Previous pelvic, urinary tract surgery or procedures (e.g. radical prostatectomy,
pelvic surgery for removal of malignancy, or bowel resection; radiotherapy, penile
implant surgery)

- Lower urinary tract malignancy, obstruction or trauma

- History or presence of prostatic carcinoma

- Current treatment with androgens, antiandrogens, estrogens, LHRH agonists/antagonists,
or anabolic steroids

- Current neurologic disease or condition associated with neurogenic bladder (e.g.
Parkinson's disease, multiple sclerosis)

- Current treatment with potent CYP3A4 inhibitors such as itraconazole or ritonavir