Status:
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
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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 min...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00644956
Start Date
June 1 2003
End Date
November 1 2003
Last Update
February 1 2021
Active Locations (2)
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1
Pfizer Investigational Site
Oslo, Norway, 0277
2
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF