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

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NCT00249730

Last updated on November 21, 2019
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Study Location
Pfizer Investigational Site
Kitchener, Ontario, Canada
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impotence
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00249730
Pfizer
Completed
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

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[email protected]

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Descriptive Information
Brief Title  ICMJE Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
Official Title  ICMJE 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
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Impotence
Intervention  ICMJE Drug: Sildenafil
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 4, 2005)		510
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented clinical diagnosis of ED by using IIEF-EF domain with score of â?¤ 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Greece,   Israel,   Italy,   Russian Federation,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00249730
Other Study ID Numbers  ICMJE A1481237
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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