ImpotencePhase 4NCT00249730
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
A Phase 4 study testing Sildenafil in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in 8 countries.
Trial summary
To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Impotence
- What is being tested?
- Sildenafil
- How many people
- 510 participants
- Where
- 39 sitesin 8 countries
- Study dates
- Oct 2005to not given
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
- Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
Who cannot join
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
- Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
United Kingdom10 sites
Pfizer Investigational Site
Ashford, Middlesex
Pfizer Investigational Site
Bath
Pfizer Investigational Site
Belmont, Durham
Pfizer Investigational Site
Chippenham, Wilts.
Pfizer Investigational Site
Coventry
Pfizer Investigational Site
Doncaster
Pfizer Investigational Site
Dundee
Pfizer Investigational Site
Glasgow
Pfizer Investigational Site
Trowbridge, Wiltshire
Pfizer Investigational Site
Weybridge, Surrey
Spain7 sites
Pfizer Investigational Site
Alicante
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Madrid
Pfizer Investigational Site
Málaga
Pfizer Investigational Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife
Pfizer Investigational Site
Seville
Pfizer Investigational Site
Valencia
Canada5 sites
Pfizer Investigational Site
Kitchener, Ontario
Pfizer Investigational Site
Saint-Léonard, Quebec
Pfizer Investigational Site
Sarnia, Ontario
Pfizer Investigational Site
Toronto, Ontario
Pfizer Investigational Site
Trois-Rivières, Quebec
Italy5 sites
Pfizer Investigational Site
Bologna
Pfizer Investigational Site
Florence
Pfizer Investigational Site
L’Aquila
Pfizer Investigational Site
Milan
Pfizer Investigational Site
Roma
France4 sites
Pfizer Investigational Site
Lille
Pfizer Investigational Site
Lyon
Pfizer Investigational Site
Montpellier
Pfizer Investigational Site
Paris
Israel4 sites
Pfizer Investigational Site
Beersheba
Pfizer Investigational Site
Haifa
Pfizer Investigational Site
Petah Tikva
Pfizer Investigational Site
Tel Aviv
Greece3 sites
Pfizer Investigational Site
Goudi, Athens
Pfizer Investigational Site
Pátrai
Pfizer Investigational Site
Thessaloniki
About this study
Official title: A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction
To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.
- Conditions
- Impotence
- Being tested
- 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.
SildenafilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IIEF erectile function domain score at the end of double blind treatment.
Secondary outcomes (1)
Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 2005
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
- Enrolment
- 510 participants
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
- NCT00249730
- Sponsor's protocol ID
- A1481237
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 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
- A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00249730
- Acronym / sponsor ID
- A1481237
- Conditions
- Impotence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- First posted
- 7 Nov 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 efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
- Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
Key exclusion criteria (2 listed)
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
- Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
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 |
|---|---|---|
| Sildenafil | Drug | – |
Primary outcome
Change in IIEF erectile function domain score at the end of double blind treatment.
1 secondary outcome
Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.
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
39 sites in 8 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 Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in 8 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 2 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 39 sites in United Kingdom, Spain, Canada, Italy, France and 3 more countries. 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?
Change in IIEF erectile function domain score at the end of double blind treatment.. 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.