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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler |
|
| Group B | Active Comparator | receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler |
|
| Group C | Active Comparator | receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler |
|
| Group D | Placebo Comparator | receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-arginine 5 gm oral caps | Drug | oral L-arginine 5 gm daily for 8 weeks |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moustafa M El Taieb, MD | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tadalafil 10 MG |
| Drug |
oral daily tadalafil 10mg for 8 weeks |
|
| serum testosterone level | Diagnostic Test | measurement of serum testosterone level |
|
| HbA1C | Diagnostic Test | measurement of HbA1C levels |
|
| penile doppler | Device | penile doppler to measure the degree of erection and penile vasculature |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |