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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00382356
Eligibility Criteria:
Inclusion Criteria:
1. Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS\> 10;Q-max \> 5cc/sec and \<10c/sec (total voided volume of at least 125cc); post void volumes \> 200cc)
2. Prostate volume \> 30cc and \< 80cc by transrectal ultrasound measurement
3. Total Serum PSA of \< 15 ng/ml (corrected for Finasteride therapy)
4. Willingness and ability to give written informed consent and comply with study instructions and procedures.
Exclusion Criteria:
1. Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
2. Total serum corrected PSA of greater than 15 ng/ml
3. History or clinical evidence of prostate cancer
4. History of acute urinary retention in three months prior.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00382356
Study Brief:
Protocol Section:
NCT00382356