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

  • STATUS
    Recruiting
Updated on 2 September 2021

Summary

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).

Description

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

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

Eligibility

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

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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.

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

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