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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kitchener, Ontario, Canada
Contact
1-800-718-1021
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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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
Intervention Model: Parallel Assignment
Masking: Double
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
Not Provided
Not Provided

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
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
Not Provided
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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