FindTrial
Sign In

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

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.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036299
Enrollment
200
Registered
2021-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Fixed dose combination of Silodosin 8 mg and Dutasteride 0.5 mg tablet in Capsule: One capsule taken orally daily with a meal for 84 days (12 weeks). Control Intervention1: Not Applicab

Sponsors

Akums Drugs Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male subjects of age 45 or above with current diagnosis of benign prostatic hyperplasia. 2. International prostate symptom score (IPSS) at presentation > 7. 3. Able to provide written informed consent and to comply with all study procedures.

Exclusion criteria

Exclusion criteria: 1. History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease. 2. Patients with Prostate-Specific Antigen (PSA) level > 4.0ng/mL 3. History of allergy to any component of the IP. 4. Patients with a residual urinary volume of â�¥250 ml. 5. Patients with severe renal impairment [Creatinine Clearance (CCr 6. Patients with severe hepatic impairment. 7. Subjects taking strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). 8. Hypersensitivity to �±1A-receptor blockers and 5 alpha-reductase inhibitors. 9. 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.

Design outcomes

Primary

MeasureTime frame
1. Mean change in International Prostate Symptom Score (IPSS). 2. Mean change in Peak Urine Flow Rate (Qmax).Timepoint: 1. Day-7 to -1 (Visit 1), Day 28Ã?±2 ( visit 3), Day 56Ã?±2 (visit 4), Day 84Ã?±2 (Visit 5) 2. Day 01 (Visit 2) and Day 84Ã?±2 (Visit 5)—

Secondary

MeasureTime frame
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 of ââ?°Â¥25%.Timepoint: 1. Day-7 to -1 (Visit 1), Day 28Ã?±2 ( visit 3), Day 56Ã?±2 (visit 4), Day 84Ã?±2 (Visit 5).—

Countries

India

Contacts

Public ContactDr Aditi Datta

Biosite Research Private Limited

aditi.datta@biositeindia.com9811788955

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026