Ejaculation Clinical Trial
Official title:
A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation
| Verified date | November 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Assessment of efficacy and safety UK-390,957.
| Status | Completed |
| Enrollment | 460 |
| Est. completion date | June 2005 |
| Est. primary completion date | June 2005 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Premature ejaculation as defined by DSM-IV Exclusion Criteria: - History of erectile dysfunction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Bondi Junction | New South Wales |
| Australia | Pfizer Investigational Site | Malvern | Victoria |
| Australia | Pfizer Investigational Site | Nedlands | Western Australia |
| Australia | Pfizer Investigational Site | Spring Hill | Queensland |
| Australia | Pfizer Investigational Site | St Leonards | New South Wales |
| Austria | Pfizer Investigational Site | Mistelbach | |
| Austria | Pfizer Investigational Site | Salzburg | |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | Montréal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Oakville | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Victoria | British Columbia |
| Czech Republic | Pfizer Investigational Site | Brno | |
| Czech Republic | Pfizer Investigational Site | Hradec Kralove | |
| Czech Republic | Pfizer Investigational Site | Prague 5 | |
| Czech Republic | Pfizer Investigational Site | Praha 2 | |
| France | Pfizer Investigational Site | Le Kremlin Bicetre | |
| France | Pfizer Investigational Site | Lyon Cedex 03 | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Hannover | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Muenchen | Bavaria |
| Israel | Pfizer Investigational Site | Beer Sheba | |
| Israel | Pfizer Investigational Site | Haifa | |
| Israel | Pfizer Investigational Site | Jerusalem | |
| Israel | Pfizer Investigational Site | Tel Hashomer | |
| Israel | Pfizer Investigational Site | Tel- Aviv | |
| Italy | Pfizer Investigational Site | Milan | |
| Italy | Pfizer Investigational Site | Roma | |
| Netherlands | Pfizer Investigational Site | Den Haag | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Norway | Pfizer Investigational Site | Bodø | |
| Norway | Pfizer Investigational Site | Moelv | |
| Norway | Pfizer Investigational Site | Oslo | |
| Poland | Pfizer Investigational Site | Bialystok | |
| Poland | Pfizer Investigational Site | Kielce | |
| Poland | Pfizer Investigational Site | Myslowice | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Sabadell | Barcelona |
| Sweden | Pfizer Investigational Site | Skovde | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Turkey | Pfizer Investigational Site | Balcali | Adana |
| Turkey | Pfizer Investigational Site | Balcova | Izmir |
| Turkey | Pfizer Investigational Site | Samanpazari | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of efficacy and safety | |||
| Secondary | Assessment of quality of sexual life |
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|---|---|---|---|
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