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

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

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

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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

Resource links provided by the National Library of Medicine


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




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).



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834610


Locations
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Egypt
Aswan University Hospital
Aswan, Egypt, 81528
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: Moustafa M El Taieb, MD Aswan University Hospital

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Responsible Party: Moustafa A. El Taieb, Ass. Prof. of Dermatology, Venereology and Andrology, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03834610     History of Changes
Other Study ID Numbers: L-arginine
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Methyltestosterone
Tadalafil
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents