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OpenTrials
Completed

NCT Number: NCT01150903

Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

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?

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Key information

Conditions

Erectile Dysfunction Cardiovascular Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

non-interventional study

Primary outcomes

  1. Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription

    Time frame: Day -92 up to Day -1 of index prescription

    Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

  2. Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91

    Time frame: Day 0 to Day 91 post index prescription

    New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

  3. Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription

    Time frame: Day -92 up to Day -1 of index prescription

    New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

  4. Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription

    Time frame: Day 366 up to Day 457 post index prescription

    New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

  5. Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period

    Time frame: Up to 3 years (Early study period - January 1999 to December 2001)

    Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

Secondary outcomes

  1. Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period

    Time frame: Up to 3 years (Early study period - January 1999 to December 2001)

    New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

  2. Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period

    Time frame: Up to 2 years (End of study period - July 2006 to June 2008)

    Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

  3. Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period

    Time frame: Up to 2 years (End of study period - July 2006 to June 2008)

    New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2010
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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