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

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: L-arginine 5 gm oral caps
* Drug: Tadalafil 10 MG
* Diagnostic Test: serum testosterone level
* Diagnostic Test: HbA1C
* Device: penile doppler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 56 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Diabetes, Tadaladil, L-arginine