Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study|
- Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD) [ Time Frame: %FMD after 6 weeks of treatment ] [ Designated as safety issue: No ]This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors.
|Study Start Date:||December 2009|
|Study Completion Date:||June 2016|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Estradiol+MPA||
1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg
Other Name: Estradiol+medroxyprogesterone acetate
|Active Comparator: Estradiol+DRSP||
1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
Other Name: Angeliq
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109979
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Ellen Seely, MD||Brigham and Women's Hospital|