ImpotencePhase 4NCT00343200
A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.
A Phase 4 study testing Viagra (sildenafil citrate) in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 48 sites in United States.
Trial summary
To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Impotence
- What is being tested?
- Viagra (sildenafil citrate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 371 participants
- Where
- 48 sitesUnited States
- Study dates
- Jul 2006to Sep 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 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men who do not identify as having ED with documented ED
- Men 30 years of age and older
- At least one prespecified risk factor for ED
Who cannot join
- Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
- Subjects with a known history of retinitis pigmentosa.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Arkansas City, Kansas, 67005
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Avon, Connecticut, 06001
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Binghamton, New York, 13901
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Colorado Springs, Colorado, 80904
Pfizer Investigational Site
Denver, Colorado, 80212
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Fort Wayne, Indiana, 46825
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Livonia, Michigan, 48152
Pfizer Investigational Site
Manchester, Connecticut, 06040
Pfizer Investigational Site
Mesa, Arizona, 85213
Pfizer Investigational Site
Mogadore, Ohio, 44260
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Newton, Kansas, 67114
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73116
Pfizer Investigational Site
Oregon, Wisconsin, 53575
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Peoria, Illinois, 61602
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Santa Rosa, California, 95405
Pfizer Investigational Site
Simpsonville, South Carolina, 29681
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
Wichita, Kansas, 67205
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wilmington, Delaware, 19801
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.
To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.
- Conditions
- Impotence
- Being tested
- Placebo, Viagra (sildenafil citrate)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Viagra (sildenafil citrate)Drug
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Sildenafil | Experimental | Not described Receives: Drug: Viagra (sildenafil citrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF).
Measured: Week 8
Secondary outcomes (2)
Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance.
Measured: Weeks 8 and 12
Safety and Tolerability
Measured: up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startJul 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 371 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
- NCT00343200
- Sponsor's protocol ID
- A1481247
- Status last verified
- Jan 2021
- First submitted
- 20 Jun 2006
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Cappelleri JC, Chambers R. Addressing Bias in Responder Analysis of Patient-Reported Outcomes. Ther Innov Regul Sci. 2021 Sep;55(5):989-1000. doi: 10.1007/s43441-021-00298-5. Epub 2021 May 27.
PubMed 34046875Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.
PubMed 28892218Shabsigh R, Kaufman J, Magee M, Creanga D, Russell D, Budhwani M. Lack of awareness of erectile dysfunction in many men with risk factors for erectile dysfunction. BMC Urol. 2010 Nov 5;10:18. doi: 10.1186/1471-2490-10-18.
PubMed 21054874
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, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.
- ClinicalTrials.gov ID
- NCT00343200
- Acronym / sponsor ID
- A1481247
- Conditions
- Impotence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Jun 2006 (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 compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Sildenafil | Experimental | Drug: Viagra (sildenafil citrate) |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men who do not identify as having ED with documented ED
- Men 30 years of age and older
- At least one prespecified risk factor for ED
Key exclusion criteria (2 listed)
- Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
- Subjects with a known history of retinitis pigmentosa.
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 |
|---|---|---|
| PlaceboPlacebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period. | Drug | Placebo |
| Viagra (sildenafil citrate)Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase). | Drug | Sildenafil |
Primary outcome
To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF).
Time frame: Week 8
2 secondary outcomes
Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance.
Time frame: Weeks 8 and 12
Safety and Tolerability
Time frame: up to 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 1 Feb 2021.
- Derived from this study: PubMed 34046875Cappelleri JC, Chambers R. Addressing Bias in Responder Analysis of Patient-Reported Outcomes. Ther Innov Regul Sci. 2021 Sep;55(5):989-1000. doi: 10.1007/s43441-021-00298-5. Epub 2021 May 27.
- Derived from this study: PubMed 28892218Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.
- Derived from this study: PubMed 21054874Shabsigh R, Kaufman J, Magee M, Creanga D, Russell D, Budhwani M. Lack of awareness of erectile dysfunction in many men with risk factors for erectile dysfunction. BMC Urol. 2010 Nov 5;10:18. doi: 10.1186/1471-2490-10-18.
- 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
48 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) in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 48 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 3 inclusion and 2 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 48 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. 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?
To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). (time frame: Week 8). 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 NCT00343200, which also lists 3 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 1 Feb 2021.