D004 vs terazosin

Comparative study of medium-term effects of D-004 and terazosin in patients with benign prostatic hyperplasia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000217

Enrollment

100

Registered

2016-09-30

Start date

2017-01-15

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Benign Prostatic Hyperplasia Lower urinary tract symptoms

Interventions

Group I (Experimental): D-004 (code research) 1 softgel capsules (320 mg) daily, by oral route for 6 months. Group II (Control): Terazosin 1 tablet (5 mg) daily, by oral route for 6 months

Adrenergic alpha-Antagonists

Fatty Acids

Plant Extracts

Administration, Oral

Tablets

Capsules

Terazosin,

Eligibility

Sex/Gender

Male

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients >= 50 years old =7, < 19 4. Enlarged prostate checked by rectal examination

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Lower 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.	—

Secondary

Measure	Time frame
Prostate size (determined by transrectal ultrasound-cm). Measuring time: at baseline, 6 months after treatment Retention volume (in mm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Symptoms relief (subjective assessment of symptoms: no changes, better, worse) Measuring time: 6 months after treatment Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline, and 2,4 and 6 months Hematologic parameters (hemoglobin (g / dL), hematocrit (%), leukocyte count (cells x 10 9 / L), red blood cells (cells x 10 12 / L), platelets (cells x 10 9 / L)). Measuring time: at baseline and 6 months. Blood chemistry parameters (Alanine amino transferase (ALT) (U/L), Aspartate aminotransferase (AST) (U/L), Glucose (mmol/L), Creatinine (mmol/L), PCR (mg/L)). Measuring time: at baseline and 6 months. Prostate-Specific Antigen test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment. The AE will measure like: - Description of the AE (name of the event) - Intensity of AE (Mild, Moderate, Severe) - Causality relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown)	—

Measure

Time frame

Prostate size (determined by transrectal ultrasound-cm). Measuring time: at baseline, 6 months after treatment Retention volume (in mm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Symptoms relief (subjective assessment of symptoms: no changes, better, worse) Measuring time: 6 months after treatment Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline, and 2,4 and 6 months Hematologic parameters (hemoglobin (g / dL), hematocrit (%), leukocyte count (cells x 10 9 / L), red blood cells (cells x 10 12 / L), platelets (cells x 10 9 / L)). Measuring time: at baseline and 6 months. Blood chemistry parameters (Alanine amino transferase (ALT) (U/L), Aspartate aminotransferase (AST) (U/L), Glucose (mmol/L), Creatinine (mmol/L), PCR (mg/L)). Measuring time: at baseline and 6 months. Prostate-Specific Antigen test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment. The AE will measure like: - Description of the AE (name of the event) - Intensity of AE (Mild, Moderate, Severe) - Causality relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown)

—

Countries

Cuba

Contacts

Public ContactJulio Fernandez Travieso

Centre of Natural Products/National Centre for Scientif Research

julio.fernandez@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026