NCT00245596

Brief Summary

The purpose of the study is to assess the sensibility of the ISL questionnaire.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

9 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

October 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

First QC Date

October 27, 2005

Last Update Submit

January 28, 2021

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

  • Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.

Secondary Outcomes (1)

  • The correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and these changes and patient reported outcomes of self-esteem

Interventions

sildenafilDRUG

Eligibility Criteria

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

You may qualify if:

  • ED patient must:
  • Be male, 18 years of age with no upper age limit;
  • Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score 25. Erectile dysfunction is defined as "the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90);
  • Have a stable female partner for at least 6 months prior to screening.

You may not qualify if:

  • Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil
  • Be currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pfizer Investigational Site

Amphion-les-Bains, France

Location

Pfizer Investigational Site

Bordeaux, France

Location

Pfizer Investigational Site

La Rochelle, France

Location

Pfizer Investigational Site

Lille, France

Location

Pfizer Investigational Site

Lyon, France

Location

Pfizer Investigational Site

Paris, France

Location

Pfizer Investigational Site

Saint-Émilion, France

Location

Pfizer Investigational Site

Thionville, France

Location

Pfizer Investigational Site

Toulouse, France

Location

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

October 1, 2005

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

FR(9)