Erectile DysfunctionNCT03834610
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
A study testing L-arginine 5 gm oral caps, Tadalafil 10 MG and serum testosterone level in people with Erectile Dysfunction, run by Aswan University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 56 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- L-arginine 5 gm oral caps, Tadalafil 10 MG and serum testosterone level
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 56 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with type 2 DM
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Erectile Dysfunction
- Being tested
- L-arginine 5 gm oral caps, Tadalafil 10 MG, serum testosterone level, HbA1C, penile doppler
- Keywords
- Erectile dysfunction, Diabetes, Tadaladil, L-arginine
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine 5 gm oral capsDrug
oral L-arginine 5 gm daily for 8 weeks
Tadalafil 10 MGDrug
oral daily tadalafil 10mg for 8 weeks
serum testosterone levelDiagnostic test
measurement of serum testosterone level
HbA1CDiagnostic test
measurement of HbA1C levels
penile dopplerDevice
penile doppler to measure the degree of erection and penile vasculature
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | receive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler Receives: Drug: L-arginine 5 gm oral caps; Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler |
| Group B | Active comparator | receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler Receives: Drug: Tadalafil 10 MG; Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler |
| Group C | Active comparator | receive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler Receives: Drug: L-arginine 5 gm oral caps; Drug: Tadalafil 10 MG; Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler |
| Group D | Placebo comparator | receive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler Receives: Diagnostic Test: serum testosterone level; Diagnostic Test: HbA1C; Device: penile doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks of treatment
Increase in Serum Total testosterone level in (nmol/L) after treatment.
Measurement of total testosterone level in (nmol/L) improvement after treatment
Measured: 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.
Measurement of penile doppler parameters improvement after treatment peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI).
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Oct 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa A. El Taieb, Aswan University Hospital
- Investigators
- Moustafa M El Taieb, MD, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834610
- Sponsor's protocol ID
- L-arginine
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03834610
- Acronym / sponsor ID
- L-arginine
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Diabetes, Tadaladil, L-arginine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: L-arginine 5 gm oral caps, Diagnostic Test: serum testosterone level, Diagnostic Test: HbA1C, Device: penile dopplerreceive L-arginine 5 g oral caps daily for 8 weeks serum testosterone level measurement penile doppler |
| Group B | Active comparator | Drug: Tadalafil 10 MG, Diagnostic Test: serum testosterone level, Diagnostic Test: HbA1C, Device: penile dopplerreceive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler |
| Group C | Active comparator | Drug: L-arginine 5 gm oral caps, Drug: Tadalafil 10 MG, Diagnostic Test: serum testosterone level, Diagnostic Test: HbA1C, Device: penile dopplerreceive L-arginine 5 g oral caps plus tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level measurement penile doppler |
| Group D | Placebo comparator | Diagnostic Test: serum testosterone level, Diagnostic Test: HbA1C, Device: penile dopplerreceive oral methyl cellulose daily for 8 weeks serum testosterone level measurement penile doppler |
Who may qualify
- Ages
- 35 to 56 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with type 2 DM
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine 5 gm oral capsoral L-arginine 5 gm daily for 8 weeks | Drug | Group A, Group C |
| Tadalafil 10 MGoral daily tadalafil 10mg for 8 weeks | Drug | Group B, Group C |
| serum testosterone levelmeasurement of serum testosterone level | Diagnostic test | Group A, Group B, Group C, Group D |
| HbA1Cmeasurement of HbA1C levels | Diagnostic test | Group A, Group B, Group C, Group D |
| penile dopplerpenile doppler to measure the degree of erection and penile vasculature | Device | Group A, Group B, Group C, Group D |
Primary outcome
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).
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moustafa M El Taieb, MD principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-arginine 5 gm oral caps, Tadalafil 10 MG and serum testosterone level in people with Erectile Dysfunction, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.