Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
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.
Timeline
- Start
- 2009-12
- Primary completion
- 2012-01
- Completion
- 2016-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estradiol | Other / unclassified | 1 mg | — |
| Comparator | drospirenone | Unknown | 0.5 mg | — |
| Subject | medroxyprogesterone acetate | Other / unclassified | 2.5 mg | — |