NCT00147628

Brief Summary

To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

20 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

First Submitted

Initial submission to the registry

September 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

First QC Date

September 4, 2005

Last Update Submit

January 28, 2021

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

  • The primary endpoints are: The changes from baseline to Visit 5 (Week 10) of the Erectile Function (Questions 1-5, 15) Intercourse Satisfaction domains (Questions 6-8) of the International Index of Erectile Function (IIEF).

Secondary Outcomes (1)

  • The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q)

Interventions

sildenafil citrateDRUG
placebo for sildenafil citrateDRUG

Eligibility Criteria

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

You may qualify if:

  • Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function

You may not qualify if:

  • Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pfizer Investigational Site

Huntsville, Alabama, United States

Location

Pfizer Investigational Site

San Diego, California, United States

Location

Pfizer Investigational Site

Aurora, Colorado, United States

Location

Pfizer Investigational Site

Miami, Florida, United States

Location

Pfizer Investigational Site

Ocala, Florida, United States

Location

Pfizer Investigational Site

Tallahassee, Florida, United States

Location

Pfizer Investigational Site

Jeffersonville, Indiana, United States

Location

Pfizer Investigational Site

Des Moines, Iowa, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, United States

Location

Pfizer Investigational Site

Garden City, New York, United States

Location

Pfizer Investigational Site

Kingston, New York, United States

Location

Pfizer Investigational Site

New York, New York, United States

Location

Pfizer Investigational Site

Poughkeepsie, New York, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, United States

Location

Pfizer Investigational Site

Houston, Texas, United States

Location

Pfizer Investigational Site

San Antonio, Texas, United States

Location

Pfizer Investigational Site

Seattle, Washington, United States

Location

Pfizer Investigational Site

Spokane, Washington, United States

Location

Related Publications (2)

  • Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.

    PMID: 28892218DERIVED

  • Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Scoring correspondence in outcomes related to erectile dysfunction treatment on a 4-point scale (SCORE-4). J Sex Med. 2009 Mar;6(3):809-19. doi: 10.1111/j.1743-6109.2008.01155.x. Epub 2009 Jan 7.

    PMID: 19143915DERIVED

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2005

First Posted

September 7, 2005

Study Start

November 1, 2005

Study Completion

September 1, 2006

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

US(20)