Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

Summary

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.

Conditions

• Menopause
• Aging

Interventions

DRUG

KUVAN

KUVAN will be given orally at 10mg/kg dose per body weight. KUVAN will be dissolved in 4-8oz water and consumed within 15 minutes.

DRUG

Placebo

Placebo pills designed to match the dissolvable KUVAN pills

DRUG

Cetrotide

Cetrotide (0.25mg/d) will be taken daily for 10 days via abdominal subcutaneous injection.

DRUG

Climara

0.075mg/d transdermal patch will be placed on skin.

DRUG

Placebo transdermal patch

Inactive transdermal patch

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Kerrie Moreau, PhD · University of Colorado School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2016-05-02

Completion

2016-05-02

Countries

• United States

Study Locations