A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.
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|ClinicalTrials.gov Identifier: NCT00343200|
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : September 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Impotence||Drug: Placebo Drug: Viagra (sildenafil citrate)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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.|
|Study Start Date :||July 2006|
|Actual 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).
- To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). [ Time Frame: Week 8 ]
- 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 ]
- Safety and Tolerability [ Time Frame: up to 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343200
Show 48 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|