Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
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| ClinicalTrials.gov Identifier: NCT03834610 |
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Recruitment Status :
Completed
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
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Sponsor:
Aswan University Hospital
Information provided by (Responsible Party):
Moustafa A. El Taieb, Aswan University Hospital
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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 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
MedlinePlus related topics:
Erectile Dysfunction
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group A
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
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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 |
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Active Comparator: Group B
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
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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 |
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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
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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 |
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Placebo Comparator: Group D
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
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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 :
- 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).
- 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
- 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
| Egypt | |
| Aswan University Hospital | |
| Aswan, Egypt, 81528 | |
Sponsors and Collaborators
Aswan University Hospital
Investigators
| Principal Investigator: | Moustafa M El Taieb, MD | Aswan University Hospital |
| 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 |
| 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:
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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 |