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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT00783094
Eligibility Criteria:
Inclusion Criteria:
* Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
* Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or 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 Visit 2.
Exclusion Criteria:
* Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
* History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
* History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
* Clinical evidence of prostate cancer at Visit 1.
* Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
* 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 (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
* Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT00783094
Study Brief:
Protocol Section:
NCT00783094