Overview

Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45. The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period.
Phase:
Phase 4
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborator:
Bayer
Treatments:
Drospirenone
Drospirenone and ethinyl estradiol combination
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate