Back to resultsDaily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
L-arginine 5 gm oral caps
Tadalafil 10 MG
serum testosterone level
HbA1C
penile doppler
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Diabetes, Tadaladil, L-arginine
Eligibility 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
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
Outcomes
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.
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.
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.
Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).
Secondary Outcome Measures
Full Information
NCT ID
NCT03834610
First Posted
February 5, 2019
Last Updated
February 7, 2019
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03834610
Brief Title
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
Official Title
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, Diabetes, Tadaladil, L-arginine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
Intervention Type
Drug
Intervention Name(s)
L-arginine 5 gm oral caps
Intervention Description
oral L-arginine 5 gm daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Tadalafil 10 MG
Intervention Description
oral daily tadalafil 10mg for 8 weeks
Intervention Type
Diagnostic Test
Intervention Name(s)
serum testosterone level
Intervention Description
measurement of serum testosterone level
Intervention Type
Diagnostic Test
Intervention Name(s)
HbA1C
Intervention Description
measurement of HbA1C levels
Intervention Type
Device
Intervention Name(s)
penile doppler
Intervention Description
penile doppler to measure the degree of erection and penile vasculature
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
8 weeks of treatment
Title
Increase in Serum Total testosterone level in (nmol/L) after treatment.
Description
Measurement of total testosterone level in (nmol/L) improvement after treatment
Time Frame
8 weeks of treatment
Title
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.
Description
Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).
Time Frame
8 weeks of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa M El Taieb, MD
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
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