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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with erectile dysfunction (ED)

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

sildenafil

Intervention Type DRUG

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

Interventions

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sildenafil

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No