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Completed

NCT Number: NCT03834610

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

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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Key information

Conditions

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

Age range

35 year–56 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospital

Aswān, 81528, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-arginine 5 gm oral caps

Drug

oral L-arginine 5 gm daily for 8 weeks

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2019
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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