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Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

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NCT01150903

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01150903
Pfizer
Completed
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

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Pfizer Clinical Trials Contact Center

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[email protected]

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Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
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?
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Patients with a PDE5 inhibitor prescription and within the age-match control.
  • Erectile Dysfunction
  • Cardiovascular Diseases
  • Male Urogenital Diseases
Other: no intervention
non-interventional study
  • PDE5 inhibitor prescription
    Intervention: Other: no intervention
  • Age-matched Control
    Intervention: Other: no intervention
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.
 
Completed
98832
August 2010
July 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01150903
A1481287
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now