Female Sexual Dysfunction |
Dyspareunia; Vaginismus |
Clinical Trial: Evaluation of the Index of Sexual Life Questionnaire
This study is not yet open for patient recruitment.
Verified by Pfizer December 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Erectile Dysfunction | Drug: sildenafil | Phase IV |
MedlinePlus related topics: Erectile Dysfunction
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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)
Secondary Outcomes: 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
Expected Total Enrollment: 120
Study start: December 2005
Eligibility
Inclusion Criteria:
ED patient must:
- Be male, ³ 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;;
Location and Contact Information
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Last Updated: December 8, 2005
Record first received: October 27, 2005
ClinicalTrials.gov Identifier: NCT00245596
Health Authority: France: AFSSAPS
ClinicalTrials.gov processed this record on 2006-01-10

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