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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

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ClinicalTrials.gov Identifier: NCT00644956
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE March 25, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date February 1, 2021
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • Drug: tadalafil
    tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
  • Drug: sildenafil
    sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Active Comparator: Arm 2
    Intervention: Drug: tadalafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)
56
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644956
Other Study ID Numbers  ICMJE A1481183
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP