ImpotencePhase 4NCT00199563
Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels
A Phase 4 study testing Viagra in people with Impotence, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns. To determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction To… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Impotence
- What is being tested?
- Viagra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Dec 2007
- Phase
- Phase 4
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years of age
- Type 2 diabetes > 6 months in duration. Men using oral hypoglycemic agents and /or insulin will be permitted into the trial.
- Stable hetero- sexual relationship for > 6 months
- IIEF score at baseline <21·
- Agrees to sign informed consent
Who cannot join
- Known hypersensitivity to sildenafil
- Use of nitrates
- Use of anti-coagulants
- History of significant heart disease, +/or myocardial infarction within last 6 months
- Unable to understand or unwilling to sign informed consent
- Concomitant use of erectogenic agent during study
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Health Care London/Urology Clinic
London, Ontario, N6A 4V2
About this study
Official title: The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study
- To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns.
- To determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction
- To assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use
- To assess if microalbuminuria predicts flow-mediated dilation (FMD) response
- To measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)
Read the detailed description
60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly blinded. Subjects will be followed by IIEF, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry.
Study time-points are at baseline, 6 and 12 weeks.
Study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.
- Conditions
- Impotence
- Being tested
- Viagra
- Keywords
- Viagra, sildenafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViagraDrug
Also called Sildenafil
Sildenafil 100mg daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| active drug | Active comparator | Viagra 100 mg / daily for 12 weeks. Receives: Drug: Viagra |
| Placebo | Placebo comparator | placebo/daily for 12 weeks Receives: Drug: Viagra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo.
Measured: 12 weeks
Secondary outcomes (1)
IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald B Brock, MD, Principal investigator, Lawson Health Research Institute/St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199563
- Sponsor's protocol ID
- R-04-402
- Other IDs
- Ethics Review: 10331, R-04-402
- Status last verified
- Nov 2018
- First submitted
- 13 Sep 2005
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu HI, Sheu WH, Lai CJ, Lee WJ, Chen YT. Endothelial dysfunction in type 2 diabetes mellitus subjects with peripheral artery disease. Int J Cardiol. 2001 Mar;78(1):19-25. doi: 10.1016/s0167-5273(00)00423-x.
PubMed 11259809De Angelis L, Marfella MA, Siniscalchi M, Marino L, Nappo F, Giugliano F, De Lucia D, Giugliano D. Erectile and endothelial dysfunction in Type II diabetes: a possible link. Diabetologia. 2001 Sep;44(9):1155-60. doi: 10.1007/s001250100616.
PubMed 11596671Feldt-Rasmussen B. Microalbuminuria, endothelial dysfunction and cardiovascular risk. Diabetes Metab. 2000 Jul;26 Suppl 4:64-6.
PubMed 10922975Desouza C, Parulkar A, Lumpkin D, Akers D, Fonseca VA. Acute and prolonged effects of sildenafil on brachial artery flow-mediated dilatation in type 2 diabetes. Diabetes Care. 2002 Aug;25(8):1336-9. doi: 10.2337/diacare.25.8.1336.
PubMed 12145231Dishy V, Sofowora G, Harris PA, Kandcer M, Zhan F, Wood AJ, Stein CM. The effect of sildenafil on nitric oxide-mediated vasodilation in healthy men. Clin Pharmacol Ther. 2001 Sep;70(3):270-9. doi: 10.1067/mcp.2001.117995.
PubMed 11557915Katz SD, Balidemaj K, Homma S, Wu H, Wang J, Maybaum S. Acute type 5 phosphodiesterase inhibition with sildenafil enhances flow-mediated vasodilation in patients with chronic heart failure. J Am Coll Cardiol. 2000 Sep;36(3):845-51. doi: 10.1016/s0735-1097(00)00790-7.
PubMed 10987609
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT00199563
- Acronym / sponsor ID
- R-04-402
- Conditions
- Impotence
- Keywords
- Viagra, sildenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- 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.
- To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns.
- To determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction
- To assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use
- To assess if microalbuminuria predicts flow-mediated dilation (FMD) response
- To measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)
Detailed description
60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly blinded. Subjects will be followed by IIEF, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry.
Study time-points are at baseline, 6 and 12 weeks.
Study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active drug | Active comparator | Drug: ViagraViagra 100 mg / daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: Viagraplacebo/daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years of age
- Type 2 diabetes > 6 months in duration. Men using oral hypoglycemic agents and /or insulin will be permitted into the trial.
- Stable hetero- sexual relationship for > 6 months
- IIEF score at baseline <21·
- Agrees to sign informed consent
Key exclusion criteria (6 listed)
- Known hypersensitivity to sildenafil
- Use of nitrates
- Use of anti-coagulants
- History of significant heart disease, +/or myocardial infarction within last 6 months
- Unable to understand or unwilling to sign informed consent
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 |
|---|---|---|
| ViagraAlso: SildenafilSildenafil 100mg daily for 12 weeks | Drug | Placebo, active drug |
Primary outcome
Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo.
Time frame: 12 weeks
1 secondary outcome
IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects
Time frame: 12 weeks
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 6 Nov 2018.
- Results publication: PubMed 11259809Yu HI, Sheu WH, Lai CJ, Lee WJ, Chen YT. Endothelial dysfunction in type 2 diabetes mellitus subjects with peripheral artery disease. Int J Cardiol. 2001 Mar;78(1):19-25. doi: 10.1016/s0167-5273(00)00423-x.
- Results publication: PubMed 11596671De Angelis L, Marfella MA, Siniscalchi M, Marino L, Nappo F, Giugliano F, De Lucia D, Giugliano D. Erectile and endothelial dysfunction in Type II diabetes: a possible link. Diabetologia. 2001 Sep;44(9):1155-60. doi: 10.1007/s001250100616.
- Results publication: PubMed 10922975Feldt-Rasmussen B. Microalbuminuria, endothelial dysfunction and cardiovascular risk. Diabetes Metab. 2000 Jul;26 Suppl 4:64-6.
- Results publication: PubMed 12145231Desouza C, Parulkar A, Lumpkin D, Akers D, Fonseca VA. Acute and prolonged effects of sildenafil on brachial artery flow-mediated dilatation in type 2 diabetes. Diabetes Care. 2002 Aug;25(8):1336-9. doi: 10.2337/diacare.25.8.1336.
- Results publication: PubMed 11557915Dishy V, Sofowora G, Harris PA, Kandcer M, Zhan F, Wood AJ, Stein CM. The effect of sildenafil on nitric oxide-mediated vasodilation in healthy men. Clin Pharmacol Ther. 2001 Sep;70(3):270-9. doi: 10.1067/mcp.2001.117995.
- Results publication: PubMed 10987609Katz SD, Balidemaj K, Homma S, Wu H, Wang J, Maybaum S. Acute type 5 phosphodiesterase inhibition with sildenafil enhances flow-mediated vasodilation in patients with chronic heart failure. J Am Coll Cardiol. 2000 Sep;36(3):845-51. doi: 10.1016/s0735-1097(00)00790-7.
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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.
Gerald B Brock, MD principal investigator
Lawson Health Research Institute/St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Viagra in people with Impotence, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 5 inclusion and 6 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 6 Nov 2018. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00199563, which also lists 6 linked publications.
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 6 Nov 2018.