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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108900
First Posted: April 22, 2010
Last Update Posted: December 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Erectile Dysfunction Drug: sildenafil Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Interventional, Prospective Study Of the Evaluation Of Patients Population With ED, Treated With Sildenafil

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS. [ Time Frame: 1 month ]

Enrollment: 100
Study Start Date: July 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: sildenafil
tables, 25,50,100 mg, on demand, 1 month

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- Patients, aged >18 years and 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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108900


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01108900     History of Changes
Other Study ID Numbers: A1481271
First Submitted: April 21, 2010
First Posted: April 22, 2010
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Pfizer:
Erectile Dysfunction udenafil sildenafil treatment satisfaction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents