A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil
- Registration Number
- NCT01108900
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with erectile dysfunction (ED) sildenafil 100 ED patients in the study that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS. 1 month