Erectile DysfunctionNCT01150903
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
An observational study of Erectile Dysfunction and Cardiovascular Diseases, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
- How many people
- 98,832 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Aug 2010
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a PDE5 inhibitor prescription and within the age-match control.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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?
- Being tested
- no intervention
- Keywords
- erectile dysfunction, phosphodiesterase inhibitor, cardiovascular diseases
- Medical subject headings
- Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
non-interventional study
no interventionOther
non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| PDE5 inhibitor prescription | Not described Receives: Other: no intervention | |
| Age-matched Control | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Up to 2 years (End of study period - July 2006 to June 2008)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 98,832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150903
- Sponsor's protocol ID
- A1481287
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2010
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 21676121