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..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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?

Conditions: Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
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 groups in NCT01150903
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.

May 2010Aug 2010

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
ClinicalTrials.gov ID: NCT01150903
Acronym / sponsor ID: A1481287
Conditions: Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
Keywords: erectile dysfunction, phosphodiesterase inhibitor, cardiovascular diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 98,832 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Jul 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 25 Jun 2010 (estimated)
Results: Posted 11 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
PDE5 inhibitor prescription	–	Other: no intervention
Age-matched Control	–	Other: no intervention

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with a PDE5 inhibitor prescription and within the age-match control.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no interventionnon-interventional study	Other	PDE5 inhibitor prescription
no interventionnon-interventional study	Other	Age-matched Control

Primary outcome

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.
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.
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.
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.
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.

3 secondary outcomes

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)
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)
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)

Results and safety

Results posted to the registry on 11 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Index PDE5i Prescription	24,708	24,708
Control (Without PDE5i Prescription)	74,124	74,124

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Index PDE5i Prescription n = 24708	Control (Without PDE5i Prescription) n = 74124
Value	70.23	55.73

Index PDE5i Prescription vs Control (Without PDE5i Prescription): p <0.001, Chi-squared

Population analysed: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Index PDE5i Prescription n = 24708	Control (Without PDE5i Prescription) n = 74124
Value	11.53	7.49

Index PDE5i Prescription vs Control (Without PDE5i Prescription): p <0.001, Chi-squared

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Index PDE5i Prescription n = 24708
Value	11.08

Population analysed: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Index PDE5i Prescription n = 24708
Value	5.65

Population analysed: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Index PDE5i Prescription	0 of 0	0 of 0	Not reported
Control (Without PDE5i Prescription)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21676121Kirby 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Erectile Dysfunction and Cardiovascular Diseases, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01150903, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.