Advertisement

Topics

Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)

2014-07-24 14:36:42 | BioPortfolio

Summary

To determine the effects, in postmenopausal women, of hormone replacement therapy on progression/regression of coronary heart disease, as measured by quantitative angiography.

Description

BACKGROUND:

The trial was a logical extension of preceding observational and cross-sectional studies on estrogen replacement therapy. Overall, the studies suggested a 50 percent reduction in risk of coronary heart disease in current estrogen users compared to non-users. In spite of such striking findings, most studies had been prone to a number of biases. One major criticism of observational studies had been that women receiving estrogen were generally healthier and more compliant than non-estrogen users.

There was a very large body of observational data suggesting that the use of estrogen in postmenopausal women reduced coronary heart disease mortality by approximately 45 percent. At the same time, there had been some concern that replacement therapy increased the likelihood of uterine cancer and perhaps breast cancer as well, although it was generally accepted that this risk was probably significantly less than the benefits obtained from the reduction of coronary heart disease mortality.

DESIGN NARRATIVE:

Randomized, double-blind, placebo-controlled. After baseline angiograms, patients were randomized to one of three arms: micronized 17-beta estradiol, 1 milligram per day; 17-beta estradiol plus medroxyprogesterone, 5 milligrams per day for twelve days per month; and placebo. Subjects in all three arms received lipid-lowering therapy, low fat/low cholesterol diet, and the HMG-CoA reductase inhibitor, pravastatin, in sufficient dosage to reduce low density lipoprotein (LDL) cholesterol levels below 130 mg/dl. The primary endpoint was progression/regression of coronary obstructive disease as measured by angiography, including the expert human panel and quantitative computer analysis. The secondary endpoint was carotid media-intima thickness determined by ultrasound. Clinical measures included lipids, lipoproteins, apolipoproteins, estradiol and medroxyprogesterone levels, urinary prostanoid metabolites, and insulin/glucose metabolism. Subjects were recruited at three centers with active coronary angiography units. Several core facilities supported the study: a Core Lipid Lab, a Reproductive Endocrine Lab, the Biostatistics Lab (Data Coordinating Center) and the Angiographic Imaging Laboratory.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Cardiovascular Diseases

Intervention

estrogen replacement therapy, hormone replacement therapy, estradiol, medroxyprogesterone

Status

Completed

Source

National Heart, Lung, and Blood Institute (NHLBI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:36:42-0400

Clinical Trials [4766 Associated Clinical Trials listed on BioPortfolio]

Hormone Estradiol Replacement Therapy Additional Herbals

The purpose of this study is to determine whether safety Study of Hormone replacement therapy (HRT) with herbals( Garlic oil+Nattokinase) for estrogen deficiency symptoms in perimenopausal...

Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information...

Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure

This study will determine whether giving estrogen replacement therapy through an estradiol patch can improve ovulation rates in women with spontaneous premature ovarian failure. The ovarie...

Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women

The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV), lopinavir/ritonavir (LPV/r), and efavirenz (EFV) change the amount of estrogen in the blood when taken alon...

Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women

Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds of all austrian women suffering from depression or anxiety disorders are over 45 years old. Th...

PubMed Articles [14819 Associated PubMed Articles listed on BioPortfolio]

Transition in Pediatric and Adolescent Hypogonadal Girls: Gynecological Aspects, Estrogen Replacement Therapy, and Contraception.

Hypogonadism may be suspected if puberty is delayed. Pubertal delay may be caused by a normal physiological variant, by primary ovarian insufficiency (Turner syndrome), or reflect congenital hypogonad...

Bazedoxifene-induced vasodilation and inhibition of vasoconstriction is significantly greater than estradiol.

A new strategy for menopausal hormone therapy replaces medroxyprogesterone with the selective estrogen receptor modulator bazedoxifene. While the agonist or antagonist activity of bazedoxifene has bee...

Screening breast magnetic resonance imaging in women with hormone replacement therapy.

The objective of this study was to compare the performance of screening mammography versus magnetic resonance imaging (MRI) in hormone replacement therapy (HRT) users.

Low estrogen doses normalize testosterone and estradiol levels to the female range in transgender women.

The ideal dosage of cross-sex hormones remains unknown. The aim of this study was to evaluate the luteinizing hormone, follicle-stimulating hormone, testosterone, estradiol and prolactin levels after ...

Establishing a Rationale for Compounding Hormone Replacement Therapy.

Why compound bioidentical hormones? Are there no similar commercial products? What is unique about the options compounding pharmacists offer compared with what is out in the marketplace? These are que...

Medical and Biotech [MESH] Definitions

The use of hormonal agents with estrogen-like activity in postmenopausal or other estrogen-deficient women to alleviate effects of hormone deficiency, such as vasomotor symptoms, DYSPAREUNIA, and progressive development of OSTEOPOROSIS. This may also include the use of progestational agents in combination therapy.

The 3-cyclopentyl ether of ETHINYL ESTRADIOL. After gastrointestinal absorption, it is stored in ADIPOSE TISSUE, slowly released, and metabolized principally to the parent compound. It has been used in ESTROGEN REPLACEMENT THERAPY. (From AMA Drug Evaluations Annual, 1992, p1011)

Therapeutic replacement or supplementation of defective or missing enzymes to alleviate the effects of the enzyme deficiency (e.g., GLUCOSYLCERAMIDASE replacement for GAUCHER DISEASE).

Therapeutic use of hormones to alleviate the effects of hormone deficiency.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

More From BioPortfolio on "Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Endocrinology
Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...


Searches Linking to this Trial