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Trial record 51 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

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

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ClinicalTrials.gov Identifier: NCT01109979
Recruitment Status : Completed
First Posted : April 23, 2010
Results First Posted : May 3, 2013
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Cardiovascular Diseases
Interventions Drug: Estradiol+MPA
Drug: Estradiol+Drospirenone
Enrollment 24
Recruitment Details Postmenopausal women ages 45 and 75 were recruited 2009- 2011 via flyers, newspaper advertisements, Craigslist, RSVP for Health, and websites.
Pre-assignment Details Subjects were excluded after screening procedures due to history of hypertension, cardiovascular disease, hyperlipidemia, diabetes, liver disease, cancer, elevated creatinine/potassium levels, abnormal thyroid function, and evidence that menopause was not completed.
Arm/Group Title E+MPA, Then E+DRSP E+DRSP, Then E+MPA
Hide Arm/Group Description Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
Period Title: Overall Study
Started 12 12
Completed 10 11
Not Completed 2 1
Reason Not Completed
Physician Decision             2             0
Withdrawal by Subject             0             1
Arm/Group Title E+MPA, Then E+DRSP E+DRSP, Then E+MPA Total
Hide Arm/Group Description Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  66.7%
10
  83.3%
18
  75.0%
>=65 years
4
  33.3%
2
  16.7%
6
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
12
 100.0%
12
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
12
 100.0%
12
 100.0%
24
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   8.3%
1
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   8.3%
1
   8.3%
2
   8.3%
White
11
  91.7%
10
  83.3%
21
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)
Hide Description 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.
Time Frame %FMD after 6 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis includes only the participants that completed a baseline assessment and at least one of the treatment arms.
Arm/Group Title E+MPA E+DRSP
Hide Arm/Group Description:
Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: % FMD after 6 weeks of treatment
5.49  (3.32) 3.39  (3.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E+MPA, E+DRSP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E+MPA E+DRSP
Hide Arm/Group Description Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
All-Cause Mortality
E+MPA E+DRSP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E+MPA E+DRSP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
E+MPA E+DRSP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
There may have been an order effect of E+DRSP on FMD. For this, however, we would expect %FMD to be lower in the 2nd treatment period, regardless of specific treatment. It is unclear whether this was true cross-over effect or due to the study size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ellen Seely, MD
Organization: Brigham and Women's Hospital
Phone: 617-732-5012
EMail: eseely@partners.org
Layout table for additonal information
Responsible Party: Ellen W. Seely, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01109979     History of Changes
Other Study ID Numbers: 2006p002137
First Submitted: April 22, 2010
First Posted: April 23, 2010
Results First Submitted: February 28, 2013
Results First Posted: May 3, 2013
Last Update Posted: July 12, 2016