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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00644956
• Collaborator: (none)
• Enrollment: 56
• Locations: 2
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 28
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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 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).

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: tadalafil; Drug: sildenafil	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2003
• Actual Study Completion Date: Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: sildenafil; sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
Active Comparator: Arm 2	Drug: tadalafil; tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. 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]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Oslo		Norway	0277
2	Pfizer Investigational Site	Leeds		United Kingdom	LS9 7TF

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00644956
• Other Study ID Numbers: A1481183
• First Posted: Mar 27, 2008
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate; Tadalafil

Study Results

No Results Posted as of Feb 1, 2021