Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
NCT00143988
ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Current sexual partner less than six months duration or sexually inactive patients
defined as engaging in sexual intercourse less than one time monthly
2. Uncontrolled hypertension (resting blood pressure >160/100); secondary hypertension;
renal failure (serum creatinine >3.0); congestive heart failure (NYHA functional Class
III-IV); acute coronary syndrome; PCI or open heart surgery within past 3 months;
cerebrovascular disease within the past 6 months and any other major medical or
psychiatric disorder.
- Individuals who regularly (more than 3 times weekly) perform rigorous physical
exercise.
- Individuals unable to perform an exercise treadmill stress test.
- Lack of informed consent
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Descriptive Information | ||||
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Brief Title | Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers | |||
Official Title | Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers | |||
Brief Summary | The purpose of this study is to determine the amount of cardiac work as measured by heart rate and blood pressure during physical exertion compared to sexual activity. | |||
Detailed Description | Physical exertion will be measured by a standardized treadmill test. Sexual activity will be performed in the study subject's home with his/her spouse or regular partner. Each study subject will wear a blood pressure and heart rate monitor at home during their sexual activity and will be asked to complete a one page diary upon completion of the activity. Normotensive and subject with mild hypertension will be studied to determine if hypertensive subjects have a relatively greater increase in their blood pressure during either physical exercise or sexual activity. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Men and women over the age of 40 who are sexually active | |||
Condition |
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Intervention |
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Study Groups/Cohorts |
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Publications * |
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* 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 | 36 | |||
Original Enrollment | 80 | |||
Actual Study Completion Date | March 2007 | |||
Actual Primary Completion Date | March 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteri 1) Male or female age 40-80 Exclusion Criteria
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Sex/Gender |
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Ages | 40 Years to 80 Years (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 | NCT00143988 | |||
Other Study ID Numbers | 3255 investigator initiated trial | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sebastian T. Palmeri, MD - Principal Investigator, UMDNJ-Robert Wood Johnson Medical School | |||
Study Sponsor | University of Medicine and Dentistry of New Jersey | |||
Collaborators | Pfizer | |||
Investigators |
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PRS Account | Rutgers, The State University of New Jersey | |||
Verification Date | August 2009 |