Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
NCT00743613
Last updated date
ABOUT THIS STUDY
Erectile dysfunction is a common complaint and is found frequently in men with
hyperlipidemia, hypertension, diabetes and those who smoke. ED may also be an early warning
of peripheral arterial disease. This study is designed to look for a relationship between the
degree of ED and the presence of PAD when associated with co-morbid conditions.
Study Location
UMass, Fitchburg Family Medicine Center
Fitchburg, Massachusetts, 01420, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction, Peripheral Arterial Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Men 50 years old or older
- Must have a history of diabetes, hypertension, hyperlipidemia and/or a history of tobacco use
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Men younger than 50 years of age
- No co-morbid condition such as diabetes, hypertension, hyperlipidemia and/or tobacco
use.
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Erectile Dysfunction, Peripheral Arterial DiseasePredicting Peripheral Arterial Disease in Men With Erectile Dysfunction
NCT00743613
- Fitchburg, Massachusetts
- Hampton, Virginia
- Newport News, Virginia
- Newport News, Virginia
- Williamsburg, Virginia
Male
50 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction | |||
| Official Title | Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction | |||
| Brief Summary | Erectile dysfunction is a common complaint and is found frequently in men with hyperlipidemia, hypertension, diabetes and those who smoke. ED may also be an early warning of peripheral arterial disease. This study is designed to look for a relationship between the degree of ED and the presence of PAD when associated with co-morbid conditions. | |||
| Detailed Description | Erectile dysfunction (ED) is a common complaint in the primary care office. It is frequently found in men with hyperlipidemia, hypertension, or diabetes, and may also be an early warning of peripheral arterial disease. We looked for a relationship between the degree of ED and the presence of PAD as measured by the Ankle Brachial Index (ABI) associated with co-morbid conditions. Men over the age of 50 with hyperlipidemia, diabetes, hypertension, or tobacco use were asked to complete a Sexual Health Inventory for Men (SHIM). An ABI was measured using a hand held Doppler. 175 men from two urban and three suburban Family Practices in Tidewater Virginia participated. Outcome measures included SHIM scores, ABI, Systolic Blood Pressure, LDL, Hemoglobin A1C and tobacco use. Moderate or severe erectile dysfunction (SHIM < 11.0) was identified in 44% of participants. More than 12.5% of men with severe ED (SHIM < 7.0) had an ABI positive for PAD at 0.95 or less. The results were adjusted for the presence of hyperlipidemia, hypertension, diabetes and tobacco use. Men with hypertension did not demonstrate a significant increase in the frequency of PAD compared to diabetics or smokers. Neither race nor age was found to increase the prevalence of ED. The complaint of erectile dysfunction in men over age 50 should prompt a physician to consider peripheral arterial disease. A simple self-administered SHIM test should help identify men at risk for PAD and suggest further evaluation if the score is 7.0 or less. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Men 50 years old or older with either diabetes, hypertension, hyperlipidemia and/or a history of tobacco use. | |||
| Condition |
| |||
| Intervention |
| |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 175 | |||
| Original Actual Enrollment | Same as current | |||
| Actual Study Completion Date | May 2008 | |||
| Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 50 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00743613 | |||
| Other Study ID Numbers | PREPARED 001 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | James Travers Edwards, Jr., MD Principal investigator, Bruton Avenue Family Practice | |||
| Study Sponsor | Bruton Avenue Family Practice | |||
| Collaborators | Pfizer | |||
| Investigators |
| |||
| PRS Account | Bruton Avenue Family Practice | |||
| Verification Date | September 2008 | |||