Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction

Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial

Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that increase the level of nitrous oxide in the smooth muscles so can increase the strength and duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil in treatment of erectile dysfunction in diabetic patients.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: L-arginine 5 gm oral caps; Diagnostic test: serum testosterone level; Diagnostic test: HbA1C; Device: penile doppler; Drug: Tadalafil 10 MG

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• patients with type 2 DM

Exclusion Criteria:

• Patients with history of pelvic trauma, major pelvic surgical intervention, hypogonadism, hyperprolactinemia, hypertension, chronic prostatitis, chronic liver disease, smokers, history of chronic intake of CNS or anti-androgen drugs and patients with Peyronie's Disease or any fibrotic anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler	Drug: L-arginine 5 gm oral caps; oral L-arginine 5 gm daily for 8 weeks; Diagnostic test: serum testosterone level; measurement of serum testosterone level; Diagnostic test: HbA1C; measurement of HbA1C levels; Device: penile doppler; penile doppler to measure the degree of erection and penile vasculature
Active Comparator: Group B; receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler	Diagnostic test: serum testosterone level; measurement of serum testosterone level; Diagnostic test: HbA1C; measurement of HbA1C levels; Device: penile doppler; penile doppler to measure the degree of erection and penile vasculature; Drug: Tadalafil 10 MG; oral daily tadalafil 10mg for 8 weeks
Active Comparator: Group C; receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler	Drug: L-arginine 5 gm oral caps; oral L-arginine 5 gm daily for 8 weeks; Diagnostic test: serum testosterone level; measurement of serum testosterone level; Diagnostic test: HbA1C; measurement of HbA1C levels; Device: penile doppler; penile doppler to measure the degree of erection and penile vasculature; Drug: Tadalafil 10 MG; oral daily tadalafil 10mg for 8 weeks
Placebo Comparator: Group D; receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler	Diagnostic test: serum testosterone level; measurement of serum testosterone level; Diagnostic test: HbA1C; measurement of HbA1C levels; Device: penile doppler; penile doppler to measure the degree of erection and penile vasculature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Index of Erectile Function score (IIEF-5) improvement after treatment. IIEF-5 score of 22-25: No erectile dysfunction (ED), 17-21: Mild ED, 12-16: Mild to moderate ED, 8-11: Moderate ED, 5-7: Severe ED.	Efficacy of oral L-arginine 5 g plus oral tadalafil 10 mg in treatment of erectile dysfunction in diabetic patients is evaluated by International Index of Erectile Function score (IIEF-5).	8 weeks of treatment
Increase in Serum Total testosterone level in (nmol/L) after treatment.	Measurement of total testosterone level in (nmol/L) improvement after treatment	8 weeks of treatment
Improvement in Penile Doppler parameters after treatment including peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI) that = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity.	Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).	8 weeks of treatment

Collaborators and Investigators

• Sponsor: Aswan University Hospital
• Investigators: Principal Investigator: Moustafa M El Taieb, MD, Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; L-arginine; Erectile dysfunction; Tadaladil
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Androgens; Tadalafil; Testosterone
• Other Study ID Numbers: L-arginine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No