A study to evaluate the safety and efficacy of fixed dose combination of Silodosin and Dutasteride in men with benign prostatic hyperplasia.

Not Applicable

Completed

• Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms,

• Registration Number: CTRI/2021/09/036299
• Lead Sponsor: Akums Drugs Pharmaceuticals Limited

Brief Summary

**A prospective, open-label, multi-center, single-arm, post-marketing****study to evaluate the safety and efficacy of fixed-dose**

**combination of Silodosin and Dutasteride in men with benign****prostatic hyperplasia.**

**PRIMARY OBJECTIVE** The primary objective of the study is to evaluate the safety of fixed dose combination of Silodosin and Dutasteride in men with benign prostatic hyperplasia.

**SECONDARY OBJECTIVE** The secondary objective of the study is to evaluate the efficacy of fixed dose combination of Silodosin and Dutasteride in men with benign prostatic hyperplasia.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Study Completion: 2021-11-17
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Male subjects of age 45 or above with current diagnosis of benign prostatic hyperplasia.
• International prostate symptom score (IPSS) at presentation > 7.
• Able to provide written informed consent and to comply with all study procedures.

Exclusion Criteria

• History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
• Patients with Prostate-Specific Antigen (PSA) level > 4.0ng/mL 3.
• History of allergy to any component of the IP.
• Patients with a residual urinary volume of ≥250 ml.
• Patients with severe renal impairment [Creatinine Clearance (CCr< 30 mL/min)].
• Patients with severe hepatic impairment.
• Subjects taking strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir).
• Hypersensitivity to α1A-receptor blockers and 5 alpha-reductase inhibitors.
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in International Prostate Symptom Score (IPSS).	1. Day-7 to -1 (Visit 1), Day 28±2 ( visit 3), Day 56±2 (visit 4), Day 84±2 (Visit 5) | 2. Day 01 (Visit 2) and Day 84±2 (Visit 5)
2. Mean change in Peak Urine Flow Rate (Qmax).	1. Day-7 to -1 (Visit 1), Day 28±2 ( visit 3), Day 56±2 (visit 4), Day 84±2 (Visit 5) | 2. Day 01 (Visit 2) and Day 84±2 (Visit 5)

Secondary Outcome Measures

Name	Time	Method
1. Change from baseline in Quality of Life (QOL) due to urinary symptoms.	2. Percentage of treatment responders achieving decrease in IPSS score from baseline

Trial Locations

Locations (2)

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Maharaja Agrasen Hospital; 🇮🇳 West, DELHI, India

King Georges Medical University

🇮🇳Lucknow, UTTAR PRADESH, India

Dr S N Sankhwar

Principal investigator

9335901693

sankhwarsn_@yahoo.com