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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01108900
First received: April 21, 2010
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108900

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01108900     History of Changes
Other Study ID Numbers: A1481271
Study First Received: April 21, 2010
Last Updated: December 16, 2011
Health Authority: Russia: Ethics Committee

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
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013