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

• ClinicalTrials.gov Identifier: NCT03834610
• Recruitment Status: Completed
• First Posted: February 8, 2019
• Last Update Posted: February 8, 2019
• Sponsor: Aswan University Hospital
• Information provided by (Responsible Party): Moustafa A. El Taieb, Aswan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Erectile Dysfunction	Drug: L-arginine 5 gm oral caps; Drug: Tadalafil 10 MG; Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: October 1, 2018
• Actual Study Completion Date: October 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 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).
2. Increase in Serum Total testosterone level in (nmol/L) after treatment. [ Time Frame: 8 weeks of treatment ]
   Measurement of total testosterone level in (nmol/L) improvement after treatment
3. 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. [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 56 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Egypt

Aswan University Hospital

Aswan, Egypt, 81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

• Principal Investigator: Moustafa M El Taieb, MD; Aswan University Hospital

More Information

• Responsible Party: Moustafa A. El Taieb, Ass. Prof. of Dermatology, Venereology and Andrology, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT03834610
• Other Study ID Numbers: L-arginine
• First Posted: February 8, 2019
• Last Update Posted: February 8, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moustafa A. El Taieb, Aswan University Hospital:

Erectile dysfunction; Diabetes; Tadaladil; L-arginine

Additional relevant MeSH terms:

Erectile Dysfunction; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Tadalafil; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Urological Agents