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Completed

NCT Number: NCT01108900

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

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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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil

Drug

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

Primary outcomes

  1. 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

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

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Non-Interventional, Prospective Study Of the Evaluation Of Patients Population With ED, Treated With Sildenafil

Acronym: SURE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2010
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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