Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Menopause, Aging

In brief

As women get older and go through menopause, levels of the female reproductive hormone estradiol decrease to low levels. Also with aging, the functioning of the arteries declines. Over time this vascular dysfunction can lead to health problems such as high blood pressure and heart disease. This study is being done to help determine what causes arteries to become unhealthy in postmenopausal women, who have low levels of the female reproductive hormone estradiol. In this study we will test whether low levels of tetrahydrobiopterin (BH4), a natural substance in the body that can cause the arteries to expand, explains why arteries become unhealthy in women with low levels of estradiol. To answer this question, we will study how vascular function changes with a medication that causes a short-term increase in BH4 levels when estradiol is lowered with a medication, compared to when estradiol is normal. We will also determine whether the administration of the antioxidant vitamin C, along with the medication to increase BH4 levels, will normalize vascular health in perimenopausal and postmenopausal women, and in women who have their estradiol levels lowered.

Key facts

Study ID

NCT02042196

Run by

University of Colorado, Denver

People needed

100

Starts

2013-12-01

Expected to finish

2016-05-02

Last updated by the study team

2019-07-11

Who can join

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

You may qualify if…

• age criteria established for pre-, peri- and postmenopausal women, and if postmenopausal at least 1 year beyond menopause
• resting blood pressure <140/90 mmHg 81; 2) plasma glucose concentrations <110 mg/dl under fasting conditions
• sedentary or recreationally active (<3 days of vigorous aerobic exercise)
• no use of OCs, HT, or other medications that might influence cardiovascular function
• nonsmokers
• no use of vitamin supplements, NSAIDS or willing to stop use for duration of the study
• not taking any other medications that would interact with cetrotide, E2 patch, or Kuvan® to confound interpretation of results

You may not qualify if…

• history of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and CVD
• known allergy to transdermal patch, GnRHant (i.e., hypersensitivity to cetrorelix, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol - the vehicle for injection of cetrorelix), or KUVAN
• history of stomach ulcer or bleeding
• other contraindications to HRT, GnRHant, and KUVAN (i.e., taking Levodopa, medications that can inhibit folate metabolism including methotrexate)
• pregnant or currently breastfeeding
• Other conditions for which individuals will be excluded from the study include: diabetes, active infection, history of seizures or disease that affects the nervous system, sepsis or an abnormal resting ECG

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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