Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Cardiovascular Disease (CVD) Clinical Trial

Official title: Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether low estrogen levels in young women with hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for cardiovascular disease.

For this study, the investigators will measuring vascular function and immune markers on:

• young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low estrogen)

• young women with regular menstrual cycles not on hormone therapy.

• recently menopausal women (<3 years from final menstrual period) not on hormone therapy.

Premenopausal HypoE participants will then be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if estrogen improves vascular and immune function.

Clinical Trial Description

Study Aims:

1. To test the hypothesis premenopausal HypoE is associated with pre-clinical CVD as determined by reductions in vascular endothelial function and increased central arterial stiffness.

2. To test the hypothesis premenopausal HypoE is associated with increased immune-mediated inflammation.

3. To test the hypothesis estrogens can reduce inflammation, improve vascular endothelial function and central arterial stiffness in premenopausal HypoE women.

In a randomized, double-blind placebo-controlled trial in premenopausal HypoE women the investigators will test 12 weeks of transdermal estradiol 0.1 mg/day patch or placebo followed by 2 weeks of estradiol plus progesterone 200mg on vascular endothelial function, arterial stiffness and immune-mediated inflammation versus placebo. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.

The investigators will be using non-invasive tests to measure vascular function including:

• Peripheral arterial tonometry (PAT)

• SphygmoCor measurements of central blood pressure

• Carotid intima-media thickness (CIMT) ;

Related Conditions & MeSH terms

• Amenorrhea
• Atherosclerosis
• Cardiovascular Disease (CVD)
• Cardiovascular Diseases
• Estrogen Deficiency
• Hypothalamic Amenorrhea
• Inflammation

• NCT number: NCT03018366
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2017
• Completion date: February 1, 2023