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

Not Applicable

Completed

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

• Registration Number: NCT03834610
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-07
• Last Update Submitted: 2019-02-07
• Study First Posted: 2019-02-08
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	L-arginine 5 gm oral caps	receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
Group B	HbA1C	receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group B	penile doppler	receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group C	HbA1C	receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group A	serum testosterone level	receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
Group B	Tadalafil 10 MG	receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group C	Tadalafil 10 MG	receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group A	penile doppler	receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
Group A	HbA1C	receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
Group D	serum testosterone level	receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
Group D	penile doppler	receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
Group C	serum testosterone level	receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group C	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
Group D	HbA1C	receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
Group B	serum testosterone level	receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
Group C	L-arginine 5 gm oral caps	receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler

Primary Outcome Measures

Name	Time	Method
Increase in Serum Total testosterone level in (nmol/L) after treatment.	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.	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).
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.	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).

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt