Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases
Intervention: Estradiol+MPA (Drug); Estradiol+Drospirenone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s): Ellen Seely, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
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.
Clinical Details
Official title: Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Additional Information
Starting date: December 2009
Last updated: June 9, 2015
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