Phase 4 N=24 Randomized Triple-blind Prevention

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

Cardiovascular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01109979 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD) — 5.49; 3.39 % FMD after 6 weeks of treatment — p=0.04

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Estradiol+MPA (Drug); Estradiol+Drospirenone (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Brigham and Women's Hospital
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)	5.49; 3.39	0.04 sig

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

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 90 mmHg and diastolic blood pressure 60 mmHg at the screening visit;
No personal history of diabetes;
Body mass index 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

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Data sourced from ClinicalTrials.gov (NCT01109979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.