Impotence Clinical Trial
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)
| NCT number | NCT00245596 |
| Other study ID # | A1481210 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | October 2005 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to assess the sensibility of the ISL questionnaire.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | |
| France | Pfizer Investigational Site | Lyon Cedex 03 | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | PARIS Cedex 13 | |
| France | Pfizer Investigational Site | Saint-Emilion | |
| France | Pfizer Investigational Site | Thionville | |
| France | Pfizer Investigational Site | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction. | |||
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00159848 -
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
|
Phase 4 | |
| Completed |
NCT00654082 -
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT00882934 -
The Management of Erectile Dysfunction With Placebo Only
|
N/A | |
| Withdrawn |
NCT00382161 -
Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
|
Phase 3 | |
| Recruiting |
NCT00297544 -
Effect of Sildenafil on Endothelial Function
|
N/A | |
| Completed |
NCT00249730 -
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
|
Phase 4 | |
| Completed |
NCT00547183 -
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
|
Phase 3 | |
| Completed |
NCT00422578 -
Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT00547092 -
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
|
Phase 4 | |
| Completed |
NCT00547508 -
To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking
|
Phase 3 | |
| Completed |
NCT00422734 -
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
|
Phase 3 | |
| Completed |
NCT00245258 -
Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
|
Phase 4 | |
| Completed |
NCT00301262 -
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
|
Phase 4 | |
| Completed |
NCT00147628 -
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire
|
Phase 4 | |
| Completed |
NCT00547287 -
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
|
Phase 3 | |
| Completed |
NCT03830164 -
Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT00498680 -
Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i
|
Phase 4 | |
| Completed |
NCT00150358 -
To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
|
Phase 4 | |
| Completed |
NCT00143221 -
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 4 | |
| Completed |
NCT00547495 -
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
|
Phase 3 |