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Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00249730
First received: November 3, 2005
Last updated: December 18, 2006
Last verified: December 2006
History of Changes

November 3, 2005
December 18, 2006
October 2005
Not Provided
Change in IIEF erectile function domain score at the end of double blind treatment.
Same as current
Complete list of historical versions of study NCT00249730 on ClinicalTrials.gov Archive Site
Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.
Same as current
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Not Provided
 
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Impotence
Drug: Sildenafil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
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Inclusion Criteria:

  • Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
  • Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.

Exclusion Criteria:

  • Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
  • Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Greece,   Israel,   Italy,   Russian Federation,   Spain,   United Kingdom
 
NCT00249730
A1481237
Not Provided
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Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP