A Multicenter, Double-Blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00645268|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Diabetes Mellitus, Type 2||Drug: sildenafil Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Double-Blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes|
|Study Start Date :||December 2002|
|Actual Study Completion Date :||January 2004|
|Active Comparator: Arm 1||
In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.
|Placebo Comparator: Arm 2||
In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.
Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).
- The IIEF Erectile Function (EF) Domain score [ Time Frame: Week 4 ]
- Intercourse success rate based on Event Logs [ Time Frame: continuous ]
- Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil [ Time Frame: continuous ]
- Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains) [ Time Frame: Week 16 ]
- Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction) [ Time Frame: Week 16 ]
- Reponses to the Global Efficacy Assessment Questions [ Time Frame: Week 16 ]
- Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function [ Time Frame: Week 4, 6, and 16 ]
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): NCT00645268
Show 29 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|