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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01109979
First received: April 22, 2010
Last updated: April 30, 2013
Last verified: April 2013
Results First Received: February 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Cardiovascular Diseases
Interventions: Drug: Estradiol+MPA
Drug: Estradiol+Drospirenone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Postmenopausal women ages 45 and 75 were recruited 2009- 2011 via flyers, newspaper advertisements, Craigslist, RSVP for Health, and websites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
E+MPA, Then E+DRSP 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
E+DRSP, Then E+MPA 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

Participant Flow:   Overall Study
    E+MPA, Then E+DRSP     E+DRSP, Then E+MPA  
STARTED     12     12  
COMPLETED     10     11  
NOT COMPLETED     2     1  
Physician Decision                 2                 0  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
E+MPA, Then E+DRSP 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
E+DRSP, Then E+MPA 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 Total of all reporting groups

Baseline Measures
    E+MPA, Then E+DRSP     E+DRSP, Then E+MPA     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     10     18  
>=65 years     4     2     6  
Gender  
[units: participants]
     
Female     12     12     24  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     12     12     24  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     11     10     21  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures

1.  Primary:   Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)   [ Time Frame: %FMD after 6 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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:  
Name/Title: Ellen Seely, MD
Organization: Brigham and Women's Hospital
phone: 617-732-5012
e-mail: eseely@partners.org


No publications provided


Responsible Party: Ellen W. Seely, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01109979     History of Changes
Other Study ID Numbers: 2006p002137
Study First Received: April 22, 2010
Results First Received: February 28, 2013
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration