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Completed

NCT Number: NCT00644956

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

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).

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil

Drug

tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Sildenafil

Drug

sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Primary outcomes

  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

    Time frame: Screening, Week 0, and Week 1

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: Screening, Week 0, and Week 1

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2003
Study completion
2003
First posted
Mar 27, 2008
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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