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View Clinical Trial (Medical Research Study)
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Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women - NCT00608062-80045 (Clinical Trial 201472)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy201472.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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Aurora |
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State:
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CO |
| Zip Code: |
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80045 |
| Conditions: |
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Arterial Stiffening - Aging - Menopause |
| Purpose: |
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The purpose of this study is to find out why women's arteries stiffen as they go through
menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with
the loss of estrogen because of "oxidative stress," the production of molecules that can
damage cells and tissues in the body, and because the arteries lose their ability to expand,
or dilate.
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| Study summary: |
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As women get older and go through menopause, estradiol levels decrease. Also with aging,
the arteries that are located around the heart get stiffer. Over time this increase in
arterial stiffness can lead to a number of health problems such as high blood pressure and
heart disease. In this study we want to find out if a short-term drop in estrogen levels in
premenopausal and perimenopausal women can cause arteries to become stiffer, and why this
happens. Additionally, in postmenopausal women, we want to find out if a short-term
increase in estrogen levels causes their arteries to become more flexible (less stiff).
Arterial health (i.e., stiffness) will be examined in premenopausal, perimenopausal and
postmenopausal women before and after they are given a drug called Ganirelix™ (for 7 days),
which will markedly lower their reproductive hormones. After the first 4 days of taking
Ganirelix™, the women will be randomly placed into 1 of 2 treatment groups to take either
estrogen (0.075 mg/d skin patch) replacement or placebo for the rest of the Ganirelix
treatment. This is to increase estrogen levels back to the normal level. After having the
patch on for 4 days, arterial health will be examined again. |
| Criteria: |
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Inclusion Criteria:
- Healthy women of all races and ethnic backgrounds in one of the following groups:
- Premenopausal: 21-35 years, regular menstrual cycles with no change in observed
cycle length (21-35 days)
- Perimenopausal: 40-55 years, categorized as either early (at least 2 cycles with
cycle length changes of at least 7 days) or late (more than 3 months of
amenorrhea) transition
- Postmenopausal: 45-70 years, more than 12 months of amenorrhea as defined by the
menopausal staging system (PENN-5); additionally, postmenopausal women will be
categorized into early and late stages as defined by the STRAW definition,
specifically, women who are less than 5 years postmenopause will be considered
early, and women more than 6 years will be categorized as late
- All postmenopausal women will have undergone natural menopause
- No oral contraceptive or HRT use for at least 6 months
- Resting blood pressure less than 140/90 mmHg
- Plasma glucose concentrations less than 110 mg/dl under fasting conditions
- Sedentary or recreationally active (less than 3 days of vigorous aerobic exercise)
- No use of medications that might influence cardiovascular function
- Nonsmokers
- No use of vitamin supplements or willing to stop use for duration of the study
Exclusion Criteria:
- History of or active estrogen-dependent neoplasms, acute liver or gallbladder
disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and
cardiovascular disease
- Known allergy to transdermal patch or GnRHant
- Other contraindications to HRT and GnRHant |
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| Study is available at: |
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University of Colorado Denver General Clinical Research Center and Exercise Research Laboratory
Aurora, CO 80045
United States
Primary Contact:
Tim Lockie, MS, MBA
Email: Tim.Lockie@uchsc.edu
Phone: 720-848-6660
Secondary Contact:
Chelsea Begman
Email: chelsea.begman@ucdenver.edu
Phone: 720-848-6475 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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