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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834610
• Other study ID #: L-arginine
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 56 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• L-arginine 5 gm oral caps
oral L-arginine 5 gm daily for 8 weeks
• Tadalafil 10 MG
oral daily tadalafil 10mg for 8 weeks

Diagnostic Test:
• serum testosterone level
measurement of serum testosterone level
• HbA1C
measurement of HbA1C levels

Device:
• penile doppler
penile doppler to measure the degree of erection and penile vasculature

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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