drugset / Trial / NCT01109979

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

NCT01109979

Phase 4 Completed 24 enrolled Brigham and Women's Hospital Bayer · collab
RandomizedCrossoverTriple-blindPrevention

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

EvaluationDrugModalityDoseRoute
Comparator Estradiol Other / unclassified 1 mg
Comparator drospirenone Unknown 0.5 mg
Subject medroxyprogesterone acetate Other / unclassified 2.5 mg