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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT00347061
Eligibility Criteria:
Inclusion Criteria:
* Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
* Suffering for at least 6 months from lower urinary tract symptoms related to BPH
* An I-PSS total score ≥ 13
* Out patient
Exclusion Criteria:
* Patients previously treated with SL77.0499-10.
* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
* Isolated bladder neck disease.
* Diagnosed carcinoma of the prostate.
* Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH.
* Patients having an indwelling catheter.
* A residual urine \> 200mL.
* Patients with Moderate or sever hepatic insufficiency.
* Known hypersensitivity to alpha1-blockers.
* Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
* Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00347061
Study Brief:
Protocol Section:
NCT00347061