Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction udenafil sildenafil treatment satisfaction
Brief summary
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.
Interventions
DRUGsildenafil
tables, 25,50,100 mg, on demand, 1 month
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS. | 1 month |
Outcome results
None listed