Erectile DysfunctionPhase 4NCT00645268
A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
A Phase 4 study testing sildenafil in people with Erectile Dysfunction and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 29 sites in 2 countries.
Trial summary
To determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Diabetes Mellitus, Type 2
- What is being tested?
- sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Dec 2002to Jan 2004
- 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 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for the duration of the study, and have a HbAlc of less than or equal to 10 at screening. Type 2 diabetic patients currently on insulin or on combination therapy with an oral hypoglycemic agent were not excluded.
Who cannot join
- Excluded were subjects who had taken more than 6 doses of any PDE5 inhibitor and/or had taken their last dose less than 4 weeks prior to the screening visit; subjects with resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg); and subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation in the last 3 months.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Pfizer Investigational Site
Baltimore, Maryland, 21224
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Beverly Hills, California, 90212
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Buffalo, New York, 14209
Pfizer Investigational Site
Duarte, California, 91010
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Kirkland, Washington, 98034
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92093
Pfizer Investigational Site
Laguna Woods, California, 92653
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Minneapolis, Minnesota, 55416
Pfizer Investigational Site
New Albany, Indiana, 47150
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
Norwalk, Connecticut, 06850
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Richmond Heights, Missouri, 63117
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229-3894
Pfizer Investigational Site
San Diego, California, 92161
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
Tacoma, Washington, 98023
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Waterbury, Connecticut, 06708
About this study
Official title: A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
To determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II). To assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR) questionnaire.
- Conditions
- Erectile Dysfunction, Diabetes Mellitus, Type 2
- Being tested
- sildenafil, placebo
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.
placeboDrug
In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.
sildenafilDrug
Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: sildenafil |
| Arm 2 | Placebo comparator | Not described Receives: Drug: placebo |
| Open-Label Arm | Other | Not described Receives: Drug: sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The IIEF Erectile Function (EF) Domain score
Measured: Week 4
Secondary outcomes (6)
Intercourse success rate based on Event Logs
Measured: continuous
Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil
Measured: continuous
Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains)
Measured: Week 16
Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction)
Measured: Week 16
Reponses to the Global Efficacy Assessment Questions
Measured: Week 16
Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function
Measured: Week 4, 6, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startDec 2002
- Study completionJan 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645268
- Sponsor's protocol ID
- A1481146
- Status last verified
- Jan 2021
- First submitted
- 20 Mar 2008
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00645268
- Acronym / sponsor ID
- A1481146
- Conditions
- Erectile Dysfunction, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Jan 2004 (actual)
- First posted
- 27 Mar 2008 (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 determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II). To assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: sildenafil |
| Arm 2 | Placebo comparator | Drug: placebo |
| Open-Label Arm | Other | Drug: sildenafil |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for the duration of the study, and have a HbAlc of less than or equal to 10 at screening. Type 2 diabetic patients currently on insulin or on combination therapy with an oral hypoglycemic agent were not excluded.
Key exclusion criteria (1 listed)
- Excluded were subjects who had taken more than 6 doses of any PDE5 inhibitor and/or had taken their last dose less than 4 weeks prior to the screening visit; subjects with resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg); and subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation in the last 3 months.
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 |
|---|---|---|
| sildenafilIn the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks. | Drug | Arm 1 |
| placeboIn the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks. | Drug | Arm 2 |
| sildenafilEligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total). | Drug | Open-Label Arm |
Primary outcome
The IIEF Erectile Function (EF) Domain score
Time frame: Week 4
6 secondary outcomes
Intercourse success rate based on Event Logs
Time frame: continuous
Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil
Time frame: continuous
Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains)
Time frame: Week 16
Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction)
Time frame: Week 16
Reponses to the Global Efficacy Assessment Questions
Time frame: Week 16
Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function
Time frame: Week 4, 6, and 16
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 1 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sildenafil in people with Erectile Dysfunction and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 29 sites in 2 countries.
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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, 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?
The IIEF Erectile Function (EF) Domain score (time frame: Week 4). 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 1 Feb 2021.