benign prostatic hyperplasia MedDRA version: 8.0 Level: LLH Classification code 10004446
Conditions
Interventions
Product Name: Prosta Fink forte (named in the protocol as "capsules with extract from pumpkin seeds")
Product Code: -
Pharmaceutical Form: Capsule*
INN or Proposed INN: n.a.
CAS Number: n.a.
Current
Sponsors
GlaxoSmithKline Consumer Healthcare GmbH & Co KG, 77815 Bühl
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - The patient’s written informed consent has been obtained - The patient must be mentally able to understand the study - BPH induced micturition symptoms must be evident at least 6 months before inclusion - Diagnosis of BPH in view of medical history and physical examination including digital rectal investigation - = 50 to 80 years old - International Prostate Symptom Score = 13 and = 19 - Residual urine = 100 ml - Prostate volume = 40 ml - Nycturia: at least twice per night - Urinary flow = 12ml/s when the micturition volume is at least 150ml - QOL = 3 - PSA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any previous treatment of BPH or micturition disorders with synthetic prostate medicines (see prohibited concomitant medication) within the last 6 months - Any previous treatment of BPH or micturition disorders with phytotherapeutic agents (see prohibited concomitant medication) within the last 6 months - prostatic carcinoma - Interventional procedures in the lower urinary tract within the last 14 days before the start of the trial - Medical conditions affecting micturition, such as irritable bladder, bladder neck contraction, urethral strictures, untreated urinary tract infection, bladder cancer, acute or chronic prostatitis, neurogenic bladder, bladder stones - Diabetes mellitus (HbA 1c>6) - Serious liver diseases (SGPT, SGOT not more than twice the upper normal range) - Serious kidney disorders - Neurological disorders (e.g. Parkinson’s disease, multiple sclerosis, spinal cord tumour, apoplexy) - Surgical intervention in the area of the lower urinary tract - Previous venereal infections - Chronic abuse of medicines, drugs or alcohol - Chronic abuse of sleeping drugs - Presence of a medical condition which, in the opinion of the investigator, would falsify the study results or could further endanger the study participant - The patient has a known hypersensitivity or allergy to substances contained in the trial medication - Participation in another clinical trial within 30 days before screening or during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Responder rate after 12 months of treatment (responders are patients with a decrease in International prostate symptom score (IPSS) by at least 5 points compared to baseline) ;Secondary Objective: - Course of the IPSS (total score) over the whole trial period - Course of the IPSS (total score) over the trial period - Course of each single item of the IPSS over the trial period - Change in nycturia - Quality of life - Duration of study participation - Reasons for premature withdrawal from the study - Tolerability: - Adverse events - Vital parameters - Physical examinations - Clinical laboratory values ;Primary end point(s): Improvement in the IPSS after 12 months of treatment | — |
Countries
Germany
Outcome results
None listed