Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

NCT ID: NCT01150903

Last Updated: 2021-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98832 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Erectile Dysfunction Cardiovascular Diseases Male Urogenital Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PDE5 inhibitor prescription

no intervention

Intervention Type OTHER

non-interventional study

Age-matched Control

no intervention

Intervention Type OTHER

non-interventional study

Interventions

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no intervention

non-interventional study

Intervention Type OTHER

no intervention

non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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

* A subject can only be selected once independent of the assignment to the target or the control populations.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

References

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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.

Reference Type DERIVED
PMID: 21676121 (View on PubMed)

Related Links

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Other Identifiers

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A1481287

Identifier Type: -

Identifier Source: org_study_id

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