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A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Oslo, , 0277 Norway
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
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

- Included subjects were 18 years of age or older

- A clinical diagnosis of erectile dysfunction

- Known responders to either 100 mg sildenafil or 20 mg tadalafil.

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

- Excluded were subjects who were unable to achieve penile rigidity of greater than or
equal to 20% at the base of the penis that was sustained for at least 3 minutes

- Subjects who are able to achieve penile rigidity of greater than or equal to 60% at
the base of the penis that was sustained for for at least 2 minutes or subjects who
are able to achieve penile rigidity of greater than or equal to 80% at the base of the
penis that is sustained for for at least 1 minute measured by Rigiscan®, at screening
with no therapy, within 60 minutes following visual sexual stimulation

- Subjects currently using any commercially available treatments for erectile
dysfunction

- Subjects on nitrates.

NCT00644956
Pfizer
Completed
A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

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A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil
A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Viagra (Sildenafil Citrate) And Cialis (Tadalafil)
The objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: tadalafil
    tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
  • Drug: sildenafil
    sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Active Comparator: Arm 2
    Intervention: Drug: tadalafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
November 2003
Not Provided

Inclusion Criteria:

  • Included subjects were 18 years of age or older
  • A clinical diagnosis of erectile dysfunction
  • Known responders to either 100 mg sildenafil or 20 mg tadalafil.

Exclusion Criteria:

  • Excluded were subjects who were unable to achieve penile rigidity of greater than or equal to 20% at the base of the penis that was sustained for at least 3 minutes
  • Subjects who are able to achieve penile rigidity of greater than or equal to 60% at the base of the penis that was sustained for for at least 2 minutes or subjects who are able to achieve penile rigidity of greater than or equal to 80% at the base of the penis that is sustained for for at least 1 minute measured by Rigiscan®, at screening with no therapy, within 60 minutes following visual sexual stimulation
  • Subjects currently using any commercially available treatments for erectile dysfunction
  • Subjects on nitrates.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway,   United Kingdom
 
 
NCT00644956
A1481183
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

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

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