To compare the efficacy and safety of tadalafil plus finasteride versus tadalafil plus dutasteride in treatment of symptomatic benign prostatic hyperplasia.

Comparative efficacy and safety assessment of tadalafil plus finasteride versus tadalafil plus dutasteride in treatment of lower urinary tract symptoms in benign prostatic hyperplasia. - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056028

Enrollment

Registered

2023-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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: Tadalafil plus Finasteride: Group A-oral Tadalafil 5mg OD plus oral Finasteride 5mg OD for 8 weeks Control Intervention1: Tadalafil plus Dutasteride: Group B-oral Tadalafil 5mg OD plus

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above 65 years of age. 2. History of lower urinary tract symptoms/benign prostatic hyperplasia for the last 6 months. 3. International Prostate Symptom Score = 13. 4. Prostate volume = 30 ml.

Exclusion criteria

Exclusion criteria: 1. Patients having hypertension, coronary artery disease, cardiac arrhythmias. 2. Patients diagnosed as a case of carcinoma prostate. 3. Patients with hepatic function impairment.

Design outcomes

Primary

Measure	Time frame
Decrease in total International Prostate Symptom ScoreTimepoint: At 0 week 4 weeks & 8 weeks	—

Secondary

Measure	Time frame
-IPSS Quality of life index score -IPSS storage subscore -IPSS voiding subscore -Decrease in prostate volume -Decrease in post voidal residual volumeTimepoint: At 0 week 4 weeks & 8 weeks	—

Countries

India

Contacts

Public ContactDr Adarsh Rag

Pt. B.D Sharma PGIMS Rohtak Haryana

adarshrag26@gmail.com7012073780

Outcome results

None listed

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