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

NCT01108900

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil
Official Title Non-Interventional, Prospective Study Of the Evaluation Of Patients Population With ED, Treated With Sildenafil
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Erectile Dysfunction
Intervention Drug: sildenafil
tables, 25,50,100 mg, on demand, 1 month
Study Groups/Cohorts 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
Intervention: Drug: sildenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2010)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:Male
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01108900
Other Study ID Numbers A1481271
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2011