Erectile Dysfunction
Conditions
Keywords
Erectile dysfunction, Diabetes, Tadaladil, L-arginine
Brief summary
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.
Interventions
DRUGL-arginine 5 gm oral caps
oral L-arginine 5 gm daily for 8 weeks
DRUGTadalafil 10 MG
oral daily tadalafil 10mg for 8 weeks
DIAGNOSTIC_TESTserum testosterone level
measurement of serum testosterone level
DIAGNOSTIC_TESTHbA1C
measurement of HbA1C levels
DEVICEpenile doppler
penile doppler to measure the degree of erection and penile vasculature
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
35 Years to 56 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 8 weeks of treatment | 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). |
| Increase in Serum Total testosterone level in (nmol/L) after treatment. | 8 weeks of treatment | Measurement of total testosterone level in (nmol/L) improvement after 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. | 8 weeks of treatment | Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI). |
Countries
Egypt
Outcome results
None listed