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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00103402
Eligibility Criteria:
Inclusion Criteria:
* Participant has signed and dated the appropriate Informed Consent document.
* Participant is male.
* Participant is at least 18 years of age.
* Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
* Symptoms bothersome enough to prompt a physician visit have been present for two years or less.
Exclusion Criteria:
* Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).
* Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
* Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
* Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.
* Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
* Participant has uninvestigated, significant hematuria.
* Participant has undergone transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
* Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00103402
Study Brief:
Protocol Section:
NCT00103402