Status:
COMPLETED
Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Arterial Stiffening
Aging
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
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 estroge...
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00608062
Start Date
March 1 2007
End Date
October 25 2012
Last Update
December 24 2020
Active Locations (1)
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1
University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory
Aurora, Colorado, United States, 80045