Overview

Evaluation of the Index of Sexual Life Questionnaire

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of the study is to assess the sensibility of the ISL questionnaire.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Sildenafil Citrate
Criteria
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.