NCT00159900

Brief Summary

The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).

Trial Health

93
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Shorter than P25 for phase_4

Geographic Reach
5 countries

23 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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

First QC Date

September 8, 2005

Last Update Submit

January 28, 2021

Conditions

Erectile Dysfunction

Keywords

Impotence

Outcome Measures

Primary Outcomes (1)

  • Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).

Secondary Outcomes (1)

  • Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction)

Interventions

Sildenafil CitrateDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male subjects aged 18-55
  • Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

You may not qualify if:

  • Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, 30130-008, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

Pfizer Investigational Site

Rio Claro, São Paulo, 13500-020, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04044-060, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04262-000, Brazil

Location

Pfizer Investigational Site

Frankfurt, 65929, Germany

Location

Pfizer Investigational Site

Marburg, 35039, Germany

Location

Pfizer Investigational Site

München, 81369, Germany

Location

Pfizer Investigational Site

München, 81925, Germany

Location

Pfizer Investigational Site

Rosenheim, D 83022, Germany

Location

Pfizer Investigational Site

Starnberg, 82319, Germany

Location

Pfizer Investigational Site

Catania, 95124, Italy

Location

Pfizer Investigational Site

Florence, 50139, Italy

Location

Pfizer Investigational Site

Roma, 00161, Italy

Location

Pfizer Investigational Site

Lodz, 90-625, Poland

Location

Pfizer Investigational Site

Lodz, 93-171, Poland

Location

Pfizer Investigational Site

Lublin, 20-008, Poland

Location

Pfizer Investigational Site

Szczecin, 71-240, Poland

Location

Pfizer Investigational Site

Warsaw, 00-911, Poland

Location

Pfizer Investigational Site

Bursa, 16070, Turkey (Türkiye)

Location

Pfizer Investigational Site

Diyarbakır, 21280, Turkey (Türkiye)

Location

Pfizer Investigational Site

Istanbul, 34900, Turkey (Türkiye)

Location

Pfizer Investigational Site

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2005

Study Completion

January 1, 2006

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

PL(5)IT(3)DE(6)BR(5)TU(4)