Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

NCT01150903

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

- Records of men aged >18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008

- no prior PDE5 inhibitor prescription before the index prescription

- continuous enrolment with medical history for ≥60 months prior to the index prescription date

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


- Records of female subjects and any male subjects not meeting the inclusion criteria
will be excluded


- A subject can only be selected once independent of the assignment to the target or the
control populations.

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Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital DiseasesIdentification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
NCT01150903
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Official Title Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
Brief Summary Erectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor treatment?
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a PDE5 inhibitor prescription and within the age-match control.
Condition
  • Erectile Dysfunction
  • Cardiovascular Diseases
  • Male Urogenital Diseases
Intervention Other: no intervention
non-interventional study
Study Groups/Cohorts
  • PDE5 inhibitor prescription
    Intervention: Other: no intervention
  • Age-matched Control
    Intervention: Other: no intervention
Publications * Kirby MG, Schnetzler G, Zou KH, Symonds T. Prevalence and detection rate of underlying disease in men with erectile dysfunction receiving phosphodiesterase type 5 inhibitors in the United Kingdom: a retrospective database study. Int J Clin Pract. 2011 Jul;65(7):797-806. doi: 10.1111/j.1742-1241.2011.02693.x.

*   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: January 11, 2011)
98832
Original Estimated Enrollment
 (submitted: June 24, 2010)
50000
Actual Study Completion Date August 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Records of men aged >18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008
  • no prior PDE5 inhibitor prescription before the index prescription
  • continuous enrolment with medical history for ?60 months prior to the index prescription date

Exclusion Criteria:

  • Records of female subjects and any male subjects not meeting the inclusion criteria will be excluded
  • A subject can only be selected once independent of the assignment to the target or the control populations.
Sex/Gender
Sexes Eligible for Study:Male
Ages 18 Years and older   (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 NCT01150903
Other Study ID Numbers A1481287
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 April 2012