Hormone study – Young Women

Mechanisms of Vascular Dysfunction in Young Women

 

Purpose:

The purpose of this study is to learn more about blood vessel function in women. With advancing age, blood vessel function declines and cardiovascular disease risk increases. The decline in estrogen with age may contribute to the decline in blood vessel function. The endothelium is the inner lining of the blood vessels, which releases substances to help control blood vessel function. One of these substances is endothelin-1 (ET-1). Ovarian hormones (such as estrogen) may alter the way ET-1 interacts with its receptors. The aims of the study are to investigate the contribution of the ET-1 receptors on the age- and hormone- related decrease in blood vessel function in women. To do this we will use a technique called microdialysis. 

 

Inclusion: You are a healthy young woman between 18-30 years of age.

Exclusion: If you use Depo-Provera, an IUD, or an extended birth control pill cycle like Seasonale or Seasonique If you take birth control pills and do not have a ‘placebo week’ Use tobacco products Have a BMI greater than 30  [calculate BMI here] History of heart disease History of blood clots, deep vein thrombosis, or other chronic disease Use hormone replacement therapy Pregnant/planning on becoming pregnant/breast feeding

Your Participation:

Full participation in this study will require 5 visits. Each visit will last between one and five hours. The first visit is at the Nurse Managed Primary Care Center. The second and fifth visits will take place at Reproductive Associates of Delaware. The third and fourth visits will take place in our lab.  The Nurse Managed Primary Care Center and our lab are located at 540 S. College Avenue (STAR Health Sciences Complex) and Reproductive Associates of Delaware is located at 4735 Ogletown Stanton Road Suite 3217 in Newark, DE.

Your participation in this research study is entirely voluntary and you have the right to stop at any time.

 

 

 

 

 

Study Design:

Within 48 hours after Visit 2, you will start giving yourself injections of ganirelix once a day, at the same time each day. You will take ganirelix for 10-12 days. ganirelix is an approved drug for women undergoing fertility treatment. For this study, we are using ganirelix to suppress and control levels of reproductive hormones to study cardiovascular function.

Visit 3 will occur during days 3-4 of ganirelix administration. After Visit 3 you will be given an estrogen patch to wear on your skin (lower abdomen). You will wear this patch for 3-4 days, and then replace it with a new patch. The study investigators will tell you which day you have to change the patch, and will remind you via phone on the day you will change the patch. You will continue using ganirelix daily while you are wearing the estrogen patch.

Visit 4 will occur on the 7th day of wearing the estrogen patch. This visit will mark the last day of wearing the estrogen patch and taking the ganirelix.

 

Compensation:

You will receive compensation for full completion of the study. Compensation amount will be described during the consent process.