Conditions: Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia dutasteride and tamsulosin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 59
Healthy volunteers: no

Brief summary:
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90 subjects will be enrolled so that among them at least 57 will complete the 6-month treatment period and evaluable for analysis.

-Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy for six month in BPH patients by monitoring category, frequency and severity of adverse events encountered during the treatment period.

-Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy with regard to symptom improvement in BPH patients by monitoring and analyzing of changes in IPSS and Qmax after 6 months of treatment.

Detailed description:
Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF collection, subject code assignment, physical examination (vital signs, demographic data, medical history); checking of inclusion and exclusion criteria: prostate symptom score according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA level, free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography (TRUS), 12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ), concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3): Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG, adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following items will be recorded: vital signs, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP doses. • Visit 4 (Month 4.5 (M4) - D135 ± 3): Following items will be recorded: treatment compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following items will be recorded: treatment compliance, vital signs, prostate symptom score according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month 7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study treatment.

Arms:
arm 1: Single arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin

Interventions: intervention 1: Dutasteride/Tamsulosin
Intervention descriptions: intervention 1: 0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment

Protocol document: