Multicentre, randomised, double-blind, placebo-controlled clinical study to assess the efficacy and safety of UroVaxom in chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS) - Uro-Vaxom in patients with chronic prostatitis and chronic pelvic pain syndrome

• Conditions: Chronic prostatitis and chronic pelvic pain syndrome; MedDRA version: 9.1Level: LLTClassification code 10009109Term: Chronic prostatitis; MedDRA version: 9.1Level: LLTClassification code 10064189Term: Chronic pelvic pain syndrome

• Registration Number: EUCTR2007-004609-85-PT
• Lead Sponsor: OM PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

- Males aged 30 to <= 60 years.
- CP/CPPS (type II or III): pain or discomfort in the pelvic region for at least 3 months in the previous 6 months. Corresponding symptoms can be perineal, lower abdominal, testicular and / or penile, rectal and lower back, suprapubic, and may be associated with ejaculatory discomfort or voiding (associated voiding symptoms are irritative or obstructive in nature, similar to symptoms associated with benign prostatic hyperplasia).
- NIH-CPSI = 15.
- Written informed consent obtained from the patients.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any prostate, bladder, or urethral cancer, seizure disorder.
- Concurrent inflammatory bowel disease, disorder affecting the bladder; liver disease
- Prior 12 months diagnosed with or treated for symptomatic genital herpes.
- Prior 3 months urinary tract infection, with a urine culture value of > 100,000 CFU/mL; clinical evidence of urethritis, sexually transmitted diseases, symptoms of acute or chronic epididymitis.
- Any pelvic radiation, systemic chemotherapy; intravesical chemotherapy; intravesical BCG, TURP, TUIP, TUIBN, TUMT, TUNA, any other prostate surgery or treatment such as cryotherapy or thermal therapy; prior treatment for orchialgia without pelvic symptoms to treatment.
- Prior 3 months prostate biopsy.
- Patients who are unable to comply with the requirements of the protocol (e.g. psychiatric problems; knowledge of language, etc.).
- Patients with a known allergy or previous intolerance or known hypersensitivity to the trial drug.
- Participation in another clinical trial and/or treatment with an experimental drug within 3 months before study start and during the present trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified