Benign prostate hyperplasia MedDRA version: 8.1 Level: LLT Classification code 10014840 Term: Enlarged prostate (benign)
Conditions
Interventions
Trade Name: Prostamol uno
Product Name: Prostamol uno
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Saw palmetto liposterolic fruit
CAS Number: NA, fruit ex
Current Sponsor code: Sabalis ser
Sponsors
Berlin-Chemie AG (Menarini Group)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patients, 50 years or older 2. IPSS = 13 3. Stable IPS score over the 4 week run-in period allowing a deviation of ± 2 points to be assessed at the randomization visit (V2) 4. PSA 150 ml 8. Prostate volume > 30 ml 9. Diagnosis of benign prostate hyperplasia upon palpation 10. QoL = 3 (assessed by QoL question of the IPSS) 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: 1. IPSS = 20 2. Prostate cancer 3. Any other malignancy 4. Bladder neck or prostate surgery 5. Lower urinary tract infection ( > 104 CFU/ml urine) 6. Patient with an indication for a surgery (anuria, macrohaematuria, recidivating urinary tract infections, concrement of the bladder, postrenal acute renal insufficiency) 7. Cystolithiasis 8. Irradiation of the pelvis 9. Any disorders causing micturition disturbances including prostatitis, neurogenic voiding disturbances 10. Urethral stricture 11. Previous veneric infections 12. Systemic immunological disorder 13. Diabetes mellitus 14. Diabetic polyneuropathy 15. Neurologic disorders 16. Abnormal liver and kidney function (twice the upper normal limit of serum aminotransferases and / or bilirubin, creatinine > 160 µmol/l), assessed at screening visit (V1) 17. Treatment for BPH with an a-blocker or any phytotherapeutic agent within 6 weeks before randomization 18. Treatment for BPH with a 5-a-reductase inhibitor within 6 months before randomization 19. Diuretics or drugs with antiandrogenic or a-receptor properties administered during the preceding 6 months for nonurological diseases (hypertension, cerebrovascular insufficiency) before randomization 20. Anticholinergic agents, anti-inflammatory drugs (NSAIDs, steroids) or any medication affecting detrusor, external or internal sphincter muscle 21. Other medication to treat bladder dysfunction: tolterodine HCL, propiverine HCL, solifenacine succinate, trospium chloride within 6 weeks before randomization. 22. Known hypersensitivity to study drug 23. Drug abuse 24. Participation in another clinical trial in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of this study is the response rate according to the IPS score based on the comparison of the results of the baseline visit (V2) and after 12 months (V7);Secondary Objective: ·Change in IPSS from baseline at randomization visit (V2) to the end of treatment after 12 months at visit 7 ·Development of IPSS over time ·Development of irritative and obstructive symptoms over time ·Changes of urodynamical examinations by measuring maximum urinary flow (Qmax) ·Changes of urodynamical examinations by measuring residual urinary volume ·Frequency of AUR ·Change in QoL ·Change in prostatic volume ·Adverse events ·Premature study withdrawals ;Primary end point(s): The primary endpoint of this study is the response rate according to the IPS score based on the comparison of the results of the baseline visit (V2) and after 12 months (V7). | — |
Countries
Germany, Lithuania
Outcome results
None listed