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

NCT ID: NCT01109979

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Estradiol+MPA

Group Type: ACTIVE_COMPARATOR

Estradiol+MPA

Intervention Type: DRUG

1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg

Estradiol+DRSP

Group Type: ACTIVE_COMPARATOR

Estradiol+Drospirenone

Intervention Type: DRUG

1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg

Interventions

Estradiol+MPA

1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg

Intervention Type: DRUG

Estradiol+Drospirenone

1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg

Intervention Type: DRUG

Other Intervention Names

Estradiol+medroxyprogesterone acetate; Angeliq

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen W. Seely

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen Seely, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2006p002137

Identifier Type: -

Identifier Source: org_study_id