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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109979
Recruitment Status : Completed
First Posted : April 23, 2010
Results First Posted : May 3, 2013
Last Update Posted : July 12, 2016
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Estradiol+MPA Drug: Estradiol+Drospirenone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study
Study Start Date : December 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: Estradiol+MPA Drug: Estradiol+MPA
1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg
Other Name: Estradiol+medroxyprogesterone acetate

Active Comparator: Estradiol+DRSP Drug: Estradiol+Drospirenone
1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
Other Name: Angeliq

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109979

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Ellen Seely, MD Brigham and Women's Hospital
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Responsible Party: Ellen W. Seely, M.D., Brigham and Women's Hospital Identifier: NCT01109979    
Other Study ID Numbers: 2006p002137
First Posted: April 23, 2010    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: July 12, 2016
Last Verified: June 2016
Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:
Cardiovascular, vascular
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Polyestradiol phosphate
Cardiovascular Diseases
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents