NCT00644956

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

First QC Date

March 25, 2008

Last Update Submit

January 28, 2021

Conditions

Erectile Dysfunction

Outcome Measures

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

    Screening, Week 0, and Week 1

Secondary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: sildenafil

Arm 2

ACTIVE COMPARATOR
Drug: tadalafil

Interventions

tadalafilDRUG

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

Arm 2
sildenafilDRUG

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Oslo, 0277, Norway

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

TadalafilSildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesPurines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 27, 2008

Study Start

June 1, 2003

Study Completion

November 1, 2003

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

NO(1)GB(1)