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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644956
First Posted: March 27, 2008
Last Update Posted: March 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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 Intervention Phase
Erectile Dysfunction Drug: tadalafil Drug: sildenafil Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: Screening, Week 0, and Week 1 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Screening, Week 0, and Week 1 ]
  • 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 [ Time Frame: Screening, Week 0, and Week 1 ]
  • 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 [ Time Frame: Screening, Week 0, and Week 1 ]

Enrollment: 56
Study Start Date: June 2003
Study Completion Date: November 2003
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644956


Locations
Norway
Pfizer Investigational Site
Oslo, Norway, 0277
United Kingdom
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644956     History of Changes
Other Study ID Numbers: A1481183
First Submitted: March 25, 2008
First Posted: March 27, 2008
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents