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

February 7, 2019 updated by: Moustafa A. El Taieb, Aswan University Hospital

Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Aswan, Egypt, 81528
        • Aswan university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A
receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler
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
Active Comparator: Group B
receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler
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
Drug: Tadalafil 10 MG
oral daily tadalafil 10mg for 8 weeks
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
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
Drug: Tadalafil 10 MG
oral daily tadalafil 10mg for 8 weeks
Placebo Comparator: Group D
receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
8 weeks of treatment
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
8 weeks of 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).
8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aswan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moustafa M El Taieb, MD, Aswan university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L-arginine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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