Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 6/17/2018 |
| Start Date: | March 2007 |
| End Date: | December 2018 |
Biological Mechanisms of Arterial Stiffening With Age and Estrogen Deficiency
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.
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.
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.
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.
Inclusion Criteria:
- Healthy women of all races and ethnic backgrounds in one of the following groups:
- Premenopausal: 18-49 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 (STRAW); 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 Hormone Replacement Therapy (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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Aurora, Colorado 80045
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