Conditions: Cardiovascular Diseases
Keywords: Cardiovascular, vascular
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Estradiol+MPA intervention 2: Estradiol+Drospirenone
Intervention descriptions: intervention 1: 1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg intervention 2: 1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg

Protocol document: