Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

NCT01150903 | Completed Results

• 1 other identifier: A1481287
• Study Type: observational
• Target: 98,832
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Erectile Dysfunction; Cardiovascular Diseases; Male Urogenital Diseases

Keywords

erectile dysfunction; phosphodiesterase inhibitor; cardiovascular diseases

Outcome Measures

Primary Outcomes (5)

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

  Day -92 up to Day -1 of index prescription

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

  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.

  Day 0 to Day 91 post index prescription

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

  Day -92 up to Day -1 of index prescription

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

  Day 366 up to Day 457 post index prescription

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

  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.

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

Secondary Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

PDE5 inhibitor prescription

Other: no intervention

Age-matched Control

Other: no intervention

Interventions

no intervention OTHER

non-interventional study

PDE5 inhibitor prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a PDE5 inhibitor prescription and within the age-match control.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 21676121 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Erectile Dysfunction; Cardiovascular Diseases; Male Urogenital Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 19, 2021
• Results First Posted: May 11, 2012

Record last verified: 2021-07