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

Last updated on November 14, 2019

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Study Location
Contact
1-800-718-1021
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.

NCT01108900
Pfizer
Completed
A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil

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Descriptive Information
Brief TitleA Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil
Official TitleNon-Interventional, Prospective Study Of the Evaluation Of Patients Population With ED, Treated With Sildenafil
Brief SummaryIn 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-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.
ConditionErectile Dysfunction
InterventionDrug: sildenafil
tables, 25,50,100 mg, on demand, 1 month
Study Groups/CohortsPatients 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 StatusCompleted
Actual Enrollment
 (submitted: April 21, 2010)
100
Original Estimated EnrollmentSame as current
Actual Study Completion DateOctober 2011
Actual Primary Completion DateOctober 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
Ages18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01108900
Other Study ID NumbersA1481271
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2011

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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