Patients with moderate LUTS (Lower Urinary Tract Symptoms) associated with benign prostatic hyperplasia MedDRA version: 7.0 Level: LLT Classification code 10004446
Conditions
Interventions
Product Name: Eviprostat N
Product Code: EVE 2004/01
Pharmaceutical Form: Coated tablet
Other descriptive name: Ethanolic extract of Chimaphila umbellata (1 : 1,5-3,0)
Concentration unit: mg milligram
Sponsors
Pharmazeutische Fabrik Evers & Co. GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Male out-patients aged 40 to 80 •Patients with LUTS (lower urinary tract symptoms) associated with BPH experiencing an I-PSS ? 13 and = 19 •Prostate Volume = 40 ml •Residual Volume = 150 ml •Willingness to pass all necessary examinations over the entire time span of 48 weeks treatment 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •I-PSS 19 •Prostate Volume > 40 ml •Residual Volume > 150 ml •Prostate cancer and transitional cell cancer of the lower and upper urogenital tract •Status after radical pelvic or urogenital surgery •Previous surgical or laser treatment of BPH •PSA level > 4.0ng/ml •Voiding volume for uroflow measurements = 150 ml •Acute or chronic infection of the urinary tract •Acute or chronic infection of the prostate •Bladder stones •Bladder shrinkage •Permanent catheterization •Acute or chronic urinary retention •Incontinence •Urethral stricture •Treatment with an alpha-blocker within the last 8 weeks •Treatment with an 5-alpha-reductase-inhibitor within the last 6 months •Disallowed concomitant treatment (cf. chapter 6.3) •Impairment of bladder function due to diabetes mellitus and/or CNS diseases (e.g. multiple sclerosis) •Other malignancies with chemotherapy or radiotherapy within the last 12 months •Life expectancy less than 3 years •Advanced renal insufficiency (creatinine > 2,2 mg/100ml) •Advanced hepatic insufficiency (SGOT/ASAT;SGPT/ALAT > 2,5 x upper normal value)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: I-PSS improvement (I-PSS12months – I-PSSbaseline adjusted for I-PSSbaseline by means of analysis of covariance) ;Secondary Objective: •Response rate; Responder definition: improvement of at least 25% in I-PSS •I-PSS Subscale Nocturia •I-PSS treatment difference after 6 months, evaluated by means of analysis of covariance with I-PSSbaseline as covariate and repeated measurements of I-PSS after 1, 2, 4, 6, 8, 10, and 12 months. •Quality of life: a) SF-36 Total score and QoL-Subscale I-PSS (Bother Score) b) sexual dysfunction: PAS SFI (Short Form) •Uroflow: a) Maximum flow-rate Qmax b) Average flow Qave c) Miction time •Post-void residual urine volume •Prostatic volume assessed by DRE Safety parameters: •Adverse events •Safety laboratory •Vital parameters ;Primary end point(s): I-PSS improvement (I-PSS12months – I-PSSbaseline adjusted for I-PSSbaseline by means of analysis of covariance) | — |
Countries
Germany
Outcome results
None listed