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

NCT ID: NCT03834610

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-10-01

Brief Summary

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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

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

L-arginine 5 gm oral caps

Intervention Type DRUG

oral L-arginine 5 gm daily for 8 weeks

serum testosterone level

Intervention Type DIAGNOSTIC_TEST

measurement of serum testosterone level

HbA1C

Intervention Type DIAGNOSTIC_TEST

measurement of HbA1C levels

penile doppler

Intervention Type DEVICE

penile doppler to measure the degree of erection and penile vasculature

Group B

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

Group Type ACTIVE_COMPARATOR

Tadalafil 10 MG

Intervention Type DRUG

oral daily tadalafil 10mg for 8 weeks

serum testosterone level

Intervention Type DIAGNOSTIC_TEST

measurement of serum testosterone level

HbA1C

Intervention Type DIAGNOSTIC_TEST

measurement of HbA1C levels

penile doppler

Intervention Type DEVICE

penile doppler to measure the degree of erection and penile vasculature

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

Group Type ACTIVE_COMPARATOR

L-arginine 5 gm oral caps

Intervention Type DRUG

oral L-arginine 5 gm daily for 8 weeks

Tadalafil 10 MG

Intervention Type DRUG

oral daily tadalafil 10mg for 8 weeks

serum testosterone level

Intervention Type DIAGNOSTIC_TEST

measurement of serum testosterone level

HbA1C

Intervention Type DIAGNOSTIC_TEST

measurement of HbA1C levels

penile doppler

Intervention Type DEVICE

penile doppler to measure the degree of erection and penile vasculature

Group D

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

Group Type PLACEBO_COMPARATOR

serum testosterone level

Intervention Type DIAGNOSTIC_TEST

measurement of serum testosterone level

HbA1C

Intervention Type DIAGNOSTIC_TEST

measurement of HbA1C levels

penile doppler

Intervention Type DEVICE

penile doppler to measure the degree of erection and penile vasculature

Interventions

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L-arginine 5 gm oral caps

oral L-arginine 5 gm daily for 8 weeks

Intervention Type DRUG

Tadalafil 10 MG

oral daily tadalafil 10mg for 8 weeks

Intervention Type DRUG

serum testosterone level

measurement of serum testosterone level

Intervention Type DIAGNOSTIC_TEST

HbA1C

measurement of HbA1C levels

Intervention Type DIAGNOSTIC_TEST

penile doppler

penile doppler to measure the degree of erection and penile vasculature

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

56 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Moustafa A. El Taieb

Ass. Prof. of Dermatology, Venereology and Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moustafa M El Taieb, MD

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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L-arginine

Identifier Type: -

Identifier Source: org_study_id

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