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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01109979
First received: April 22, 2010
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Drug: Estradiol+MPA
Drug: Estradiol+Drospirenone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD) [ Time Frame: %FMD after 6 weeks of treatment ] [ Designated as safety issue: No ]
    This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors.


Enrollment: 24
Study Start Date: December 2009
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Estradiol+MPA Drug: Estradiol+MPA
1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg
Other Name: Estradiol+medroxyprogesterone acetate
Active Comparator: Estradiol+DRSP Drug: Estradiol+Drospirenone
1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
Other Name: Angeliq

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109979

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Bayer
Investigators
Principal Investigator: Ellen Seely, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Ellen W. Seely, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01109979     History of Changes
Other Study ID Numbers: 2006p002137
Study First Received: April 22, 2010
Results First Received: February 28, 2013
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Cardiovascular, vascular

Additional relevant MeSH terms:
Cardiovascular Diseases
Drospirenone
Drospirenone and ethinyl estradiol combination
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Diuretics
Diuretics, Potassium Sparing
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on November 20, 2014