Evaluation of the Index of Sexual Life Questionnaire

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00245596
• Collaborator: (none)
• Enrollment: 120
• Locations: 11
• Patients Per Site: 10.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: sildenafil	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)
• Study Start Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Amphion-Les-Bains		France
2	Pfizer Investigational Site	Bordeaux		France
3	Pfizer Investigational Site	La Rochelle		France
4	Pfizer Investigational Site	Lille		France
5	Pfizer Investigational Site	Lyon Cedex 03		France
6	Pfizer Investigational Site	Lyon		France
7	Pfizer Investigational Site	PARIS Cedex 13		France
8	Pfizer Investigational Site	Paris		France
9	Pfizer Investigational Site	Saint-Emilion		France
10	Pfizer Investigational Site	Thionville		France
11	Pfizer Investigational Site	Toulouse		France

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00245596
• Other Study ID Numbers: A1481210
• First Posted: Oct 28, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021