Benign Prostatic Hyperplasia Study – BPH
Research Study Seeking Participants
A Randomized, Double-blind, Placebo-controlled Dose-ranging Study of OPK- 88004 Once-a-day Dosing for 16 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia
or fill out the form to inquire about participating
Men with Benign Prostatic Hyperplasia (BPH) have an enlarged prostate gland, which causes lower urinary tract symptoms. One type of drug (5-ARis) approved for the treatment of BPH prevents the actions of testosterone, a male sex hormone, on the prostate to reduce prostate size, improve the symptoms, and reduce the risk of complications. Other types of treatment do not reduce prostate size, but improve the symptoms only.
OPK-88004 acts to block the effects of testosterone on the prostate, and may reduce its excessive growth. This may improve lower urinary tract symptoms.
Nearly half of men at age 50 will have an enlarged prostate, and incidence increases with age. About 2 million men are treated for it annually in the United States.
David B. Jack, MD, FAAFP, FAABP
TODD FURNESS, DO, FAAFP
Lone Peak Clinic – Physicians’ Research Options, LLC
11760 S 700 E, #112
Draper, UT 84020
(801) 816-3925 – Research office
If you are 45 years of age or older and you have an enlarged prostate, you may be able to participate in the ZEAL clinical research study. The study will evaluate the effects of the study drug compared to placebo (no active ingredients) on prostate volume, which may relieve associated symptoms.
Why is this study being done?
This study is being done to see whether or not OPK-88004 will reduce the size of the prostate in men with enlarged prostates with urinary tract symptoms, and to see its effects on a blood marker associated with prostate size, prostate specific antigen (PSA). It will also see how safe OPK-88004 is at the doses to be given in this study.
About 126 men with BPH will participate in this study at approximately 35 study centers in the United States. Your participation in the study will last approximately 24 weeks, and will include approximately 9 study visits to the center. Depending on the study clinic, you may need to travel to a different location or return on another day to complete certain study procedures. On two visits, you may be asked to stay longer at the center, or return for additional blood draws later the same day.