Impotence Clinical Trial
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
| NCT number | NCT00249730 |
| Other study ID # | A1481237 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | October 2005 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 510 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Kitchener | Ontario |
| Canada | Pfizer Investigational Site | Sarnia | Ontario |
| Canada | Pfizer Investigational Site | St. Leonard | Quebec |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Trois-Rivieres | Quebec |
| France | Pfizer Investigational Site | Lille | |
| France | Pfizer Investigational Site | LYON Cedex 03 | |
| France | Pfizer Investigational Site | Montpellier | |
| France | Pfizer Investigational Site | PARIS cedex 18 | |
| Greece | Pfizer Investigational Site | Goudi | Athens |
| Greece | Pfizer Investigational Site | Patras | |
| Greece | Pfizer Investigational Site | Thessaloniki | |
| Israel | Pfizer Investigational Site | Beer Sheba | |
| Israel | Pfizer Investigational Site | Haifa | |
| Israel | Pfizer Investigational Site | Petach Tikva | |
| Israel | Pfizer Investigational Site | Tel- Aviv | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | L'Aquila | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Roma | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Spain | Pfizer Investigational Site | Alicante | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | La Laguna | Santa Cruz De Tenerife |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| United Kingdom | Pfizer Investigational Site | Ashford | Middlesex |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Belmont | Durham |
| United Kingdom | Pfizer Investigational Site | Chippenham | Wilts. |
| United Kingdom | Pfizer Investigational Site | Coventry | |
| United Kingdom | Pfizer Investigational Site | Doncaster | |
| United Kingdom | Pfizer Investigational Site | Dundee | |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Trowbridge | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Weybridge | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Canada, France, Greece, Israel, Italy, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in IIEF erectile function domain score at the end of double blind treatment. | |||
| Secondary | Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability. |
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