drugset / Trial / NCT02042196

Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

NCT02042196

RandomizedParallel-groupQuadruple-blindBasic science

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.

Timeline

Start
2013-12
Primary completion
2016-05-02
Completion
2016-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetrorelix Other / unclassified 0.25 mg Subcutaneous
Subject Estradiol Other / unclassified 0.075 mg Other
Subject sapropterin Unknown 10 mg/kg Oral

Indications

No indication recorded.