EFFECT OF TESTOSTERON THERAPY ON LOW URINARY TRACT

• Conditions: metabolic syndrome and BPH patients who will undergo simple prostatectomy; MedDRA version: 14.1Level: LLTClassification code 10004447Term: Benign prostatic hypertrophySystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-003494-26-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-26
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult male subjects (=18 years old) who are planned fror simple prostatectomy for BPH 2. Diagnosis of Metabolic syndrome(according to AHA/NHLBI) 3. ddiagnosis of prostatic inflammation (NIH-CPSI score >15) 4. Able to understand the study procedures and to sign informed written consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Partecipation to another clinical study 2. Previous diagnosis of breast or prostatic cancer 3. PSA >4ng/mL 4. Hematocrit =52% 5. Use of 5alpha-reductase inhibitors in the previous 3 months ; 6. Psychiatruic disorders 7. Severe disease that unable the patient to partecipate to the study 8. Severe hypersensitivity to the drug

Study & Design

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