Summary:
Click image to enlargeThe ZEAL clinical research study is for men ages 45 and older, who have an enlarged prostate (also known as BPH, Benign prostatic hyperplasia) The study will look at the effect of the study drug (OPK-88004) compared to placebo on prostate volume, which may be associated with lower urinary tract signs and symptoms.
OPK-88004 is a capsule taken by mouth once per day. It is conseidered an investigational medication inthis study because it has not been approved by the US Food and Drug Administraion (FDA) and other regulatory aurhorities for treating BPH.
Participants in the ZEAL study will be randomly assigned, like the flip of a coin, to receive either a 15mg dose of OPK-88004, 25mg dose OPK-88004, or placebo.
There will be 3 phases to this study: a 4-week screening period, followed by a 16-week treatment period, and a 4-week follow-up period. Participants will attend approximately 9 visits at the study site.
- Men over 45 years old
- Have BPH
- Common symptoms of BPH:
- Frequent Urination
- Excessive Urination at night
- Sense of incomplete bladder emptying
- Weak urinary stream
- Willing to NOT take or STOP any of the listed medication below:
- Herbal supplements: red clover, ginkgo bioba, gotu kola, muira puama, tribulus, damiana, maitake, licorice root, ginseng, hawthorn, wild yam, horny goal week, Cholest-Natural
- Phytotherapies: Saw Palmetto, Prostata, Yohimbine, Pygeum Africanum
- Over the Counter supplements: Tren, Epi-Tren, Stakabol, Black Mass, Tren Stack
- PDE5 Inhibitors for erectile dysfuction are allowed with restrictive use. Do not take 72 hours prior to a study visits:
- Viagra, Cialis, and Levitra
- Have Flexible Schedule
Qualified Participants May Receive:
- Comprehensive Physical Exam
- Complimentary assessment:
- Transrectal Ultrasound
- Uroflowmetry Assessment
- Bladder Ultrasound
- Total Body Composition Scan
- Comprehensive blood results
- Semen Analysis