A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.
This study has been completed.
Information provided by:
First received: June 20, 2006
Last updated: September 9, 2008
Last verified: September 2008
To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. [ Time Frame: Weeks 8 and 12 ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: up to 12 Weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2006|
|Study Completion Date:||September 2007|
|Placebo Comparator: Placebo||
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Drug: Viagra (sildenafil citrate)
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343200
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Sponsors and Collaborators
|Study Director:||Pfizer CT.gov Call Center||Pfizer|