Evaluation of the Index of Sexual Life Questionnaire

Viatris

Status and phase: Completed; Phase 4

Conditions: Impotence

Treatments: Drug: sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245596

A1481210

Details and patient eligibility

About

The purpose of the study is to assess the sensibility of the ISL questionnaire.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)