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CompletedNCT00245596Updated Feb 1, 2021

Evaluation of the Index of Sexual Life Questionnaire

A Phase 4 interventional study of sildenafil in Impotence, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 11 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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

02

Conditions studied

  • Impotence

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 120 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants

Interventions

  • Drugsildenafil
06

What researchers measure

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

07

Study locations

11 sites
  • Pfizer Investigational Site
    Amphion-Les-Bains, France
  • Pfizer Investigational Site
    Bordeaux, France
  • Pfizer Investigational Site
    La Rochelle, France
  • Pfizer Investigational Site
    Lille, France
  • Pfizer Investigational Site
    Lyon Cedex 03, France
  • Pfizer Investigational Site
    Lyon, France
  • Pfizer Investigational Site
    PARIS Cedex 13, France
  • Pfizer Investigational Site
    Paris, France
  • Pfizer Investigational Site
    Saint-Emilion, France
  • Pfizer Investigational Site
    Thionville, France
  • Pfizer Investigational Site
    Toulouse, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00245596
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Oct 28, 2005
Start date
Oct 2005
Last update
Feb 1, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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