Benign prostatic hyperplasia (BPH) N40
Conditions
Interventions
Group 1: Pumpkin seed powder extract EFLA®940, 500 mg/day p.o. (tablet), for 12 weeks
Sponsors
Apomedica Pharmazeutische Produkte GmbH
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Suffering from symptoms of BHP for at least 6 month before screening; PSA <4 ng/mL; IPSS at least 8 at screening; Nocturia: at least 1-2 per night
Exclusion criteria
Exclusion criteria: History of prostatic surgery or other invasive or minimally invasive procedures to treat BPH; Has other conditions that may cause urinary symptoms (e.g. bladder malignancy, acute or chronic urinary tract infections, etc.); History or evidence of prostate cancer; BMI >40 kg/m2 (Class III obesity); HbA1c >6.5 at screening in non-diabetic subjects, HbA1c >7.5 in subjects under medical treatment of diabetics; Gastrointestinal diseases/conditions; Heavy smoker >15 cigarettes/day; History of surgery of the prostate, bladder or urethra; Use of any other medications or dietary supplements for treatment of BPH, associated symptoms and erectile dysfunction in the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Explorative evaluation: Investigation of the following parameters at the beginning and measurement of the change over the intervention period of 12 weeks: -IPSS -Quality of life (IPSS) -Bladder diaries (frequency, nocturia) -Peak flow urinary flow rate (Qmax) -Sonographic determination of postvoid residual urine volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional parameters: -International Index of Erectile Function (IIEF) -Global assessment -Tolerability -Blood routine parameter inclusive PSA | — |
Countries
Germany
Contacts
Public ContactMartin Leibbrand
Urologische Praxis Dr. Leibbrand
Outcome results
None listed