Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Summary

The Barbra Streisand Women’s Heart Center invites you to participate in a new study designed to evaluate the impact of estrogen on your heart health. We know that low estrogen levels are not healthy in young women, and we want to see if it will affect your heart health in the future. We are looking to compare three groups of women:

1. women 18-40 years old who have missed three or more periods in a row
2. women 18-40 years old who have regular monthly periods
3. women 50 years or older and recently in menopause (less than three years)

Each woman will undergo blood draws and blood vessel function testing. Parking will be validated, and you will receive compensation upon completion of the study.

If you or someone you know is interested, please call 310-423-9666 and reference code HYPO E.


HypoE (Hypoestrogenemia)

Women will be eligible if they have missed three menstrual cycles in a row due to low estrogen and are between the ages of 18-40 years. Each woman will undergo blood draws and blood vessel function testing, using a noninvasive ultrasound and tonometer. After the baseline visit, you will also be given an estrogen patch or a placebo patch, which will help to evaluate blood vessel function. These results will be compared to young women who have regular monthly periods and older women who are recently postmenopausal. These tests are free of charge to all participants, and you will receive your laboratory evaluations. Parking will be validated. Compensation is $300 gift card upon completion of the study, which is up to seven visits.


Normal Control

Each woman will undergo blood draws and blood vessel function testing. Parking will be validated, and a $50 gift card will be given upon completion of the study which is up to two visits.


Menopause

Each woman will undergo blood draws and blood vessel function testing. These tests are free of charge to all participants. Parking will be validated and a $50 gift card will be given upon completion of study.


Key Inclusion Criteria (Normal Control and HypoE)

  • Premenopausal, not on hormone therapy
  • Has missed three or more monthly menstrual cycles in a row or has normal monthly menstrual cycles
  • English speaking (for the purposes of complete self-assessments)
  • Able to give informed consent
  • Between 18-40 years old


Key Exclusion Criteria (Normal Control and HypoE)

  • Pregnant in past 12 months or nursing in last six months
  • Smoking
  • High blood pressure
  • High blood cholesterol
  • Diabetes
  • Currently on hormonal therapy or birth control pills


Key Inclusion Criteria (Menopause)

  • Recently menopausal (within three years of final menstrual period)
  • English speaking (for the purposes of complete self-assessments)
  • Able to give informed consent
  • 50 years of age or older
  • Has not taken hormone replacement therapy or estrogen since entering menopause


Key Exclusion Criteria (Menopause)

  • Pregnant in past 12 months or nursing in last six months
  • Smoking
  • High blood pressure
  • High blood cholesterol
  • Diabetes
  • Medications, including psychotropic or illicit drugs
  • Surgical menopause
  • Primary ovarian insufficiency or premature ovarian failure
  • Chemotherapy induced menopause


Principal Investigator

Chrisandra Shufelt, MD


Co-Investigators

C. Noel Bairey Merz, MD
Margareta Pisarska, MD
Janet Wei, MD


Study Contact

Chrisandra Shufelt MD

Phone: 310-423-9660
Email: shufeltc@cshs.org


Status

Active


IRB No.

Pro00026081


IRB Approval Expiration Date

08/31/2017