Quality of Erection Study
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159900
First received: September 8, 2005
Last updated: April 4, 2008
Last verified: April 2008
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Purpose
The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Sildenafil Citrate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).
Secondary Outcome Measures:
- Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction)
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | January 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male subjects aged 18-55
- Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)
Exclusion Criteria:
- Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening]
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159900
Locations
| Brazil | |
| Pfizer Investigational Site | |
| Belo Horizonte, MG, Brazil, 30130-008 | |
| Pfizer Investigational Site | |
| Rio de Janeiro, RJ, Brazil, 20551-030 | |
| Pfizer Investigational Site | |
| Rio Claro, SP, Brazil, 13500-020 | |
| Pfizer Investigational Site | |
| Sao Paulo, SP, Brazil, 04044-060 | |
| Pfizer Investigational Site | |
| Sao Paulo, SP, Brazil, 04262-000 | |
| Germany | |
| Pfizer Investigational Site | |
| Frankfurt, Germany, 65929 | |
| Pfizer Investigational Site | |
| Marburg, Germany, 35039 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81369 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81925 | |
| Pfizer Investigational Site | |
| Rosenheim, Germany, D 83022 | |
| Pfizer Investigational Site | |
| Starnberg, Germany, 82319 | |
| Italy | |
| Pfizer Investigational Site | |
| Catania, Italy, 95124 | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50139 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00161 | |
| Poland | |
| Pfizer Investigational Site | |
| Lodz, Poland, 93-171 | |
| Pfizer Investigational Site | |
| Lodz, Poland, 90-625 | |
| Pfizer Investigational Site | |
| Lublin, Poland, 20-008 | |
| Pfizer Investigational Site | |
| Szczecin, Poland, 71-240 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 00-911 | |
| Turkey | |
| Pfizer Investigational Site | |
| Bursa, Turkey, 16070 | |
| Pfizer Investigational Site | |
| Diyarbakir, Turkey, 21280 | |
| Pfizer Investigational Site | |
| Istanbul, Turkey, 34900 | |
| Pfizer Investigational Site | |
| Izmir, Turkey, 35100 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00159900 History of Changes |
| Other Study ID Numbers: | A1481222 |
| Study First Received: | September 8, 2005 |
| Last Updated: | April 4, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Pfizer:
|
Impotence |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Sildenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013