CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Estradiol+MPA +1 moredrug
Likely dose
Estradiol+MPA 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01109979
NCT01109979Phase 4Completed

Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study

Brigham and Women's Hospital·interventional·Posted Apr 23, 2010·Updated Jul 12, 2016

In Brief

A Phase 4 clinical trial evaluating Estradiol+MPA and Estradiol+Drospirenone for Cardiovascular Diseases. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2010
Enrollment StartDec 1, 2009
Primary CompletionJan 1, 2012
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.2 years ago

Interventions

Estradiol+MPAdrug

1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg

Estradiol+Drospirenonedrug

1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg