ImpotencePhase 4NCT00137072
Mild To Moderate Erectile Dysfunction Study
A Phase 4 study testing Viagra (Sildenafil Citrate) 100 mg in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in United States.
Trial summary
Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Impotence
- What is being tested?
- Viagra (Sildenafil Citrate) 100 mg
- How many people
- 355 participants
- Where
- 33 sitesUnited States
- Study dates
- Apr 2005to Feb 2006
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
Who cannot join
- Subjects with penile implants
- Subjects with a known history of retinitis pigmentosa.
- Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Pfizer Investigational Site
Aurora, Colorado
Pfizer Investigational Site
Bay Shore, New York
Pfizer Investigational Site
Beverly Hills, California
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Des Moines, Iowa
Pfizer Investigational Site
Fort Wayne, Indiana
Pfizer Investigational Site
Gainesville, Florida
Pfizer Investigational Site
Hattiesburg, Mississippi
Pfizer Investigational Site
Homewood, Alabama
Pfizer Investigational Site
Hoover, Alabama
Pfizer Investigational Site
Huntsville, Alabama
Pfizer Investigational Site
Jeffersonville, Indiana
Pfizer Investigational Site
Kingston, New York
Pfizer Investigational Site
La Mesa, California
Pfizer Investigational Site
Lacey, Washington
Pfizer Investigational Site
Las Vegas, Nevada
Pfizer Investigational Site
Middlebury, Connecticut
Pfizer Investigational Site
Nashville, Tennessee
Pfizer Investigational Site
New Orleans, Louisiana
Pfizer Investigational Site
New Port Richey, Florida
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Newport Beach, California
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Poughkeepsie, New York
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
Shreveport, Louisiana
Pfizer Investigational Site
South Miami, Florida
Pfizer Investigational Site
Spokane, Washington
Pfizer Investigational Site
Tallahassee, Florida
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Waterbury, Connecticut
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study of Men With Mild to Moderate Erectile Dysfunction to Evaluate the Efficacy of Viagra 8 Hours Post-Dose
Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
- Conditions
- Impotence
- Being tested
- Viagra (Sildenafil Citrate) 100 mg
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagra (Sildenafil Citrate) 100 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
Secondary outcomes (1)
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startApr 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpotenceStudies 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
- 355 participants (actual)
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
- NCT00137072
- Sponsor's protocol ID
- A1481230
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2005
- Last updated
- 1 Feb 2021
- Results posted
- 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
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study of Men With Mild to Moderate Erectile Dysfunction to Evaluate the Efficacy of Viagra 8 Hours Post-Dose
- ClinicalTrials.gov ID
- NCT00137072
- Acronym / sponsor ID
- A1481230
- Conditions
- Impotence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 29 Aug 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.
Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
Key exclusion criteria (3 listed)
- Subjects with penile implants
- Subjects with a known history of retinitis pigmentosa.
- Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
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 |
|---|---|---|
| Viagra (Sildenafil Citrate) 100 mg | Drug | – |
Primary outcome
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
1 secondary outcome
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.
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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Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
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Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
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Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
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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
33 sites 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 (Sildenafil Citrate) 100 mg in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in United States.
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 2 inclusion and 3 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 33 sites in United States. 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. 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?
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.. 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.