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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Erectile Dysfunction

Interventions

sildenafilDRUG

tables, 25,50,100 mg, on demand, 1 month

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To observe the treatment satisfaction of ED patients (sum of questions 13-14 IIEF) that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated.

Time frame: 1 month

Secondary Outcomes

To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS.

Time frame: 1 month

Data from ClinicalTrials.gov

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