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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: tadalafil (Drug); sildenafil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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).
Clinical Details
Official title: 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)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary efficacy variable was time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Secondary outcome: The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 5 minutes following visual sexual stimulationTime to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 5 minutes following visual sexual stimulation The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, Oslo 0277, Norway
Pfizer Investigational Site, Leeds LS9 7TF, United Kingdom
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: June 2003
Last updated: March 26, 2008
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