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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0277
        • Pfizer Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Screening, Week 0, and Week 1

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Screening, Week 0, and Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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