Impotence
Conditions
Brief summary
The purpose of the study is to assess the sensibility of the ISL questionnaire.
Interventions
DRUGsildenafil
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Outcome results
None listed