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

Completed · Phase 4

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT01109979

Run by

Brigham and Women's Hospital

People needed

24

Starts

2009-12-01

Expected to finish

2016-06-01

Last updated by the study team

2016-07-12

Who can join

Age: 45 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Current smoking, defined as smoking within the 12 months before the screening visit;
• Alcohol intake >1 beverage per night or history of alcohol abuse;
• Current or past recreational drug use;
• 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;
• Risk factors for arterial or venous thromboembolism;
• Personal history of breast cancer or any other type of cancer;
• Personal history of endometrial hyperplasia, endometrial cancer, or unexplained vaginal bleeding;
• History of cervical cancer or abnormal pap smear
• Prescription or herbal medication use, excluding thyroid hormone supplementation;
• Ischemic changes on resting electrocardiogram;
• Serum creatinine ≥ 1.3 mg/dL.
• Serum potassium level > 5.0 mmol/L;
• Known hypersensitivity to any of the study drugs;
• Other active medical problems detected by examination or laboratory testing, except for treated hypothyroidism.
• Pregnancy

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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