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

Aswan University Hospital

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Diagnostic Test: HbA1C; Drug: L-arginine 5 gm oral caps; Device: penile doppler; Drug: Tadalafil 10 MG; Diagnostic Test: serum testosterone level

Study type: Interventional

Funder types: Other

Identifiers

NCT03834610

L-arginine

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: Male

Ages: 35 to 56 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 4 patient groups, including a placebo group

Group A

Active Comparator group

Description:

receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler

Treatment:

Device: penile doppler

Diagnostic Test: HbA1C

Drug: L-arginine 5 gm oral caps

Diagnostic Test: serum testosterone level

Group B

Active Comparator group

Description:

receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler

Treatment:

Device: penile doppler

Drug: Tadalafil 10 MG

Diagnostic Test: HbA1C

Diagnostic Test: serum testosterone level

Group C

Active Comparator group

Description:

receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler

Treatment:

Device: penile doppler

Drug: Tadalafil 10 MG

Diagnostic Test: HbA1C

Drug: L-arginine 5 gm oral caps

Diagnostic Test: serum testosterone level

Group D

Placebo Comparator group

Description:

receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler

Treatment:

Device: penile doppler

Diagnostic Test: HbA1C

Diagnostic Test: serum testosterone level