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. NCT03297398, SAR-202

Updated on 2 September 2021


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).


For more information contact Cheryl Zinar, Director of Clinical Research, Urologic Consultants of Southeastern PA, 610-667-0458, Czinar@ucsepa.com.

Condition Benign Prostatic Hyperplasia (Enlarged Prostate)
Clinical Study IdentifierTX196750
Last Modified on2 September 2021


Yes No Not Sure

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 cancer
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note