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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT00401661
Eligibility Criteria:
Inclusion criteria:
* Patients suffering from moderate to severe LUTS suggestive of BPH
* I-PSS total score ≥ 8
* Patients sexually active
Exclusion criteria:
* Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
* Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
* Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
* Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
* Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
* History of postural hypotension or syncope
* Known hypersensitivity to alfuzosin
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00401661
Study Brief:
Protocol Section:
NCT00401661