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

Condition(s) targeted: Cardiovascular Diseases

Intervention: Estradiol+MPA (Drug); Estradiol+Drospirenone (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Ellen Seely, MD, Phone: 617 732 5012, Email: eseely@partners.org

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.

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: Improvement in endothelial function as measured by brachial artery reactivity

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

Ellen Seely, MD, Phone: 617 732 5012, Email: eseely@partners.org

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Ellen Seely, MD, Phone: 617-732-5012, Email: eseely@partners.org

Starting date: December 2009
Last updated: June 22, 2011