Effects of a pumpkin seed powder extract EFLA(R)940, a food supplement, on symptom frequency and severity in men with BPH

Not Applicable

• Conditions: Benign prostatic hyperplasia (BPH); N40; Hyperplasia of prostate

• Registration Number: DRKS00011044
• Lead Sponsor: Apomedica Pharmazeutische Produkte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-03
• Study Completion: 2017-10-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Explorative evaluation: <br>Investigation of the following parameters at the beginning and measurement of the change over the intervention period of 12 weeks:<br>-IPSS <br>-Quality of life (IPSS) <br>-Bladder diaries (frequency, nocturia) <br>-Peak flow urinary flow rate (Qmax)<br>-Sonographic determination of postvoid residual urine volume<br>

Secondary Outcome Measures

Name	Time	Method
Additional parameters:<br>-International Index of Erectile Function (IIEF)<br>-Global assessment<br>-Tolerability<br>-Blood routine parameter inclusive PSA