Not Signed In -
Impotence |
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Clinical Trial: Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire
This study is not yet open for patient recruitment.
Verified by Pfizer September 2005
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Purpose
To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man''''s sexual experience into one comprehensive questionnaire.
| Condition | Intervention | Phase |
|---|---|---|
| Impotence | Drug: sildenafil citrate Drug: placebo for sildenafil citrate | Phase IV |
MedlinePlus related topics: Erectile Dysfunction
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Multi-Center, Double-Blind Placebo Controlled, Flexible-Dose Study With An Open-Label Phase To Assess The Efficacy Of Sildenafil Citrate On Erectile Function And Intercourse Satisfaction As Well As To Validate The Sexual Experience Questionnaire And Its Treatment Responsiveness In Men With Erectile Dysfunction
Further Study Details:
Primary Outcomes: The primary endpoints are:; The changes from baseline to Visit 5 (Week 10) of the Erectile Function (Questions 1-5, 15); Intercourse Satisfaction domains (Questions 6-8) of the International Index of Erectile Function (IIEF).
Secondary Outcomes: The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q); The change from baseline to Visit 4 (Week 6), Visit 5
Expected Total Enrollment: 180
Secondary Outcomes: The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q); The change from baseline to Visit 4 (Week 6), Visit 5
Expected Total Enrollment: 180
Study start: October 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function
Exclusion Criteria:
- Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00147628
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1481236
Last Updated: September 6, 2005
Record first received: September 4, 2005
ClinicalTrials.gov Identifier: NCT00147628
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 6, 2005
Record first received: September 4, 2005
ClinicalTrials.gov Identifier: NCT00147628
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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