Quality of Erection Study
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00159900
Collaborator
(none)
300
23
8
13
1.6
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date
:
May 1, 2005
Study Completion Date
:
Jan 1, 2006
Outcome Measures
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) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Belo Horizonte | MG | Brazil | 30130-008 |
| 2 | Pfizer Investigational Site | Rio de Janeiro | RJ | Brazil | 20551-030 |
| 3 | Pfizer Investigational Site | Rio Claro | SP | Brazil | 13500-020 |
| 4 | Pfizer Investigational Site | Sao Paulo | SP | Brazil | 04044-060 |
| 5 | Pfizer Investigational Site | Sao Paulo | SP | Brazil | 04262-000 |
| 6 | Pfizer Investigational Site | Frankfurt | Germany | 65929 | |
| 7 | Pfizer Investigational Site | Marburg | Germany | 35039 | |
| 8 | Pfizer Investigational Site | Muenchen | Germany | 81369 | |
| 9 | Pfizer Investigational Site | Muenchen | Germany | 81925 | |
| 10 | Pfizer Investigational Site | Rosenheim | Germany | D 83022 | |
| 11 | Pfizer Investigational Site | Starnberg | Germany | 82319 | |
| 12 | Pfizer Investigational Site | Catania | Italy | 95124 | |
| 13 | Pfizer Investigational Site | Firenze | Italy | 50139 | |
| 14 | Pfizer Investigational Site | Roma | Italy | 00161 | |
| 15 | Pfizer Investigational Site | Lodz | Poland | 90-625 | |
| 16 | Pfizer Investigational Site | Lodz | Poland | 93-171 | |
| 17 | Pfizer Investigational Site | Lublin | Poland | 20-008 | |
| 18 | Pfizer Investigational Site | Szczecin | Poland | 71-240 | |
| 19 | Pfizer Investigational Site | Warszawa | Poland | 00-911 | |
| 20 | Pfizer Investigational Site | Bursa | Turkey | 16070 | |
| 21 | Pfizer Investigational Site | Diyarbakir | Turkey | 21280 | |
| 22 | Pfizer Investigational Site | Istanbul | Turkey | 34900 | |
| 23 | Pfizer Investigational Site | Izmir | Turkey | 35100 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00159900
Other Study ID Numbers:
- A1481222
First Posted:
Sep 12, 2005
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms: