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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

April 22, 2010
April 30, 2013
December 2009
January 2012   (final data collection date for primary outcome measure)
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.
Improvement in endothelial function as measured by brachial artery reactivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Effects of medication on brachial artery reactivity assessed at end of each of two six-week study periods
Complete list of historical versions of study NCT01109979 on ClinicalTrials.gov Archive Site
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Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Drug: Estradiol+MPA
    1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg
    Other Name: Estradiol+medroxyprogesterone acetate
  • Drug: Estradiol+Drospirenone
    1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
    Other Name: Angeliq
  • Active Comparator: Estradiol+MPA
    Intervention: Drug: Estradiol+MPA
  • Active Comparator: Estradiol+DRSP
    Intervention: Drug: Estradiol+Drospirenone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy female postmenopausal volunteers, as defined by absence of menses for at least 12 months and follicle stimulating hormone (FSH) 30 IU/L;
  2. Age 45 to 75 years;
  3. Systolic blood pressure <140 and >90 mmHg and diastolic blood pressure <90 and >60 mmHg at the screening visit;
  4. No personal history of diabetes;
  5. Body mass index < 30 kg/m2;
  6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram).

Exclusion Criteria:

  1. Current smoking, defined as smoking within the 12 months before the screening visit;
  2. Alcohol intake >1 beverage per night or history of alcohol abuse;
  3. Current or past recreational drug use;
  4. Personal history of hypertension, cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), hyperlipidemia, diabetes (defined as a fasting glucose ≥126 mg/dL), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression, or illness requiring overnight hospitalization in the past 6 months;
  5. Risk factors for arterial or venous thromboembolism;
  6. Personal history of breast cancer or any other type of cancer;
  7. Personal history of endometrial hyperplasia, endometrial cancer, or unexplained vaginal bleeding;
  8. History of cervical cancer or abnormal pap smear
  9. Prescription or herbal medication use, excluding thyroid hormone supplementation;
  10. Ischemic changes on resting electrocardiogram;
  11. Serum creatinine ≥ 1.3 mg/dL.
  12. Serum potassium level > 5.0 mmol/L;
  13. Known hypersensitivity to any of the study drugs;
  14. Other active medical problems detected by examination or laboratory testing, except for treated hypothyroidism.
  15. Pregnancy
Female
45 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01109979
2006p002137
Yes
Ellen W. Seely, Brigham and Women's Hospital
Brigham and Women's Hospital
Bayer
Principal Investigator: Ellen Seely, MD Brigham and Women's Hospital
Brigham and Women's Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP