D004 vs terazosi

Phase 3

• Conditions: Benign Prostatic Hyperplasia; Lower urinary tract symptoms; Prostatic Hyperplasia; Prostatic Diseases; Genital Diseases, Male; Male Urogenital Diseases

• Registration Number: RPCEC00000217
• Lead Sponsor: Centre of Natural Products/National Centre for Scientifc Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Patients >= 50 years old <=80 years old
2. Informed consent
3. IPSS score between >=7, < 19
4. Enlarged prostate checked by rectal examination

Exclusion Criteria

1. Prostate Cancer.
2. Prior urological surgery.
3. Urinary retention.
4. Urinary tract infection.
5. Criteria to be catheterized in next 3 months.
6. PSA> 5 ng / mL .
7. Acute myocardial infarction, stroke, transient ischemic attack or major surgery within 6 months previous.
8. History of heart failure.
9. History of hepatic failure.
10. Blood Pressure > 180/110 mm Hg.
11. Diagnosed neoplasias.
12. Treatment with alpha 1 adrenergic antagonists, inhibitors of 5-alpha reductase, androgens,antiandrogens, cholinergics, anticholinergics,steroids and/or phytotherapy for BPH in 6 months prior study.
13. Alcoholism.
14. Psychiatric problems that limit its response to IPSS.
15. Common history of drug allergy or any other condition that affects patient´s health and life during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ower Urinary Tract Symptoms (evaluated by International Prostate Symptom Score: IPSS: Mild 1-7, Moderate 8-18, Severe 19-35). Measuring time: at baseline, and at 2, 4 and 6 months.