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

NCT03834610 | Completed

• 1 other identifier: L-arginine
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; Diabetes; Tadaladil; L-arginine

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Group A

ACTIVE COMPARATOR

receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler

Drug: L-arginine 5 gm oral caps; Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler

Group B

ACTIVE COMPARATOR

receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler

Drug: Tadalafil 10 MG; Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: 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

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

Group D

PLACEBO COMPARATOR

receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler

Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler

Interventions

L-arginine 5 gm oral caps DRUG

oral L-arginine 5 gm daily for 8 weeks

Group A; Group C

Tadalafil 10 MG DRUG

oral daily tadalafil 10mg for 8 weeks

Group B; Group C

serum testosterone level DIAGNOSTIC_TEST

measurement of serum testosterone level

Group A; Group B; Group C; Group D

HbA1C DIAGNOSTIC_TEST

measurement of HbA1C levels

Group A; Group B; Group C; Group D

penile doppler DEVICE

penile doppler to measure the degree of erection and penile vasculature

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 35 Years - 56 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with type 2 DM

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Moustafa M El Taieb, MD

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. of Dermatology, Venereology and Andrology

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 8, 2019
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)