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

Aswan University Hospital108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Erectile Dysfunction

Interventions

L-arginine 5 gm oral capsDRUG

oral L-arginine 5 gm daily for 8 weeks

Tadalafil 10 MGDRUG

oral daily tadalafil 10mg for 8 weeks

serum testosterone levelDIAGNOSTIC_TEST

measurement of serum testosterone level

Eligibility

Sex: MALEMin age: 35 YearsMax age: 56 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Aswan University Hospital

Aswān, Egypt

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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).

Time frame: 8 weeks of treatment

Data from ClinicalTrials.gov

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