A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil (SURE)

Viatris

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Drug: sildenafil

Study type: Observational

Funder types: Industry

Identifiers

NCT01108900

A1481271

Details and patient eligibility

About

In the present study, it is planned to observe a population of 100 ED patients treated previously with udenafil and for whom their physician decided to switch them to sildenafil because of poor udenafil tolerance and/or poor efficacy.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients aged ≥ 18 years.
• Clinical diagnosis of erectile dysfunction supported by a total score of less than or equal to 21 according to Sexual Health Inventory-Male (SHI-M).
• Patients having a sexual partner throughout the study.
• Patients having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks.

Exclusion criteria

• The patients for whom sildenafil is contraindicated according to the Local Product Document (LPD). (See appendix D)
• The patients for whom sexual activity is not indicated.

Trial design

100 participants in 1 patient group

Patients with erectile dysfunction (ED)

Description:

100 ED patients in the study that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated

Treatment:

Drug: sildenafil