Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Estradiol+MPA; Estradiol+Drospirenone
Intervention description: 1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg; 1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
Intervention MeSH terms: Medroxyprogesterone Acetate; Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: Female
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiovascular, vascular

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.
    

Eligibility 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