A parallel, randomised, double blind, placebo controlled study to investigate the effect of SagaPro on nocturia in men

INTERVENTION: Product Name: SagaPro Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Nocturia ; MedDRA version: 12.1 Level: LLT Classification code 10029446 Term: Nocturia PRIMARY OUTCOME: Main Objective: The primary study objective is to assess the effect of SagaPro compared with placebo, given once daily in the evening, in reducing bothersome LUTS, especially nocturia, often associated in men with BPH. Primary end point(s): The primary endpoint is the change in the number of nocturnal voids from baseline until after 8 weeks on SagaPro/placebo treatment. Secondary Objective: Other objectives include investigating the effect of SagaPro on sleep time and prostatic symptoms and QoL according to the International prostate symptom score (I‐PSS) INCLUSION CRITERIA: Each participant must meet the following criteria to be enrolled in this study: 1. Male volunteers with bothersome LUTS, 50‐80 years of age. 2. Willing and able to complete the micturition diary and questionnaires correctly. 3. An average of =3 nocturnal voids per night as determined by the participant diary (average over nights of the screening period). 4. I‐PSS total score of =8 and the I‐PSS QoL score of =3. 5. Written informed consent. 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