Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

Completed · Not applicable · Has a placebo group

Conditions studied: Arterial Stiffening, Aging, Menopause

In brief

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.

Key facts

Study ID

NCT00608062

Run by

University of Colorado, Denver

People needed

155

Starts

2007-03-01

Expected to finish

2012-10-25

Last updated by the study team

2020-12-24

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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