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

Erectile Dysfunction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644956
• Other study ID #: A1481183
• Status: Completed
• Phase: Phase 4
• Start date: June 2003
• Est. completion date: November 2003

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• tadalafil
tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
• sildenafil
sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Locations

Country	Name	City	State
Norway	Pfizer Investigational Site	Oslo
United Kingdom	Pfizer Investigational Site	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Screening, Week 0, and Week 1
Secondary	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 stimulation		Screening, Week 0, and Week 1
Secondary	Time 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		Screening, Week 0, and Week 1
Secondary	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		Screening, Week 0, and Week 1

External Links

•   To obtain contact information for a study center near you, click here.