Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT00861757
Eligibility Criteria:
Inclusion Criteria:
* Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
* Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
* Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment
Exclusion Criteria:
* Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
* History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
* History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
* Clinical evidence of prostate cancer at initiation
* Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
* History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
* History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
* Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT00861757
Study Brief:
Protocol Section:
NCT00861757