European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)

2014-08-27 03:49:10 | BioPortfolio


The objective of the active surveillance study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users over a study period of 3 to 6 years. Also, all other serious adverse events will be analyzed.


The safety of a novel drug product containing a new chemical entity should be assessed in an extensive post marketing safety surveillance program. It is also prudent to assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to the special pharmacological characteristics of the novel drug product. Differentiating between the inherent background population risk and a potential incremental risk due to treatment is often challenging. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavour.

The primary objective of the study, the European Active Surveillance Study of Women taking HRT (EURAS-HRT), is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. This active surveillance study will assess pertinent cardiovascular outcomes in new HRT users over a study period of 3 to 6 years. Also, all other serious adverse events will be reported.

The new drug product under surveillance in the EURAS - HRT study is Angeliq®, which contains the novel synthetic progestagen drospirenone (DRSP) combined with estradiol. In addition, all other oral combined HRT products with a novel progestagen that will be newly marketed during the study period could be included in this study. These new HRT products will be compared with established HRT products.

As estrogen/progestagen combinations increase the risk for thromboembolism, all new drug products that contain a novel estrogen or progestagen should be investigated for their influence on venous and arterial thromboembolic events rates. A large, prospective, controlled cohort study of OC users (EURAS OC study), which compared DRSP-containing OC users with other OC users, demonstrated that DRSP is not associated with an increased incidence for any of the above-mentioned adverse events in OC users. However, because OC users are two to three decades younger than the typical HRT user the results of the OC study can only partially be extrapolated to older age groups.

The combined cohort will include at least 30,000 women recruited in several European countries. At least 90,000 years of observation are expected from the field work which will end around 2010.

The participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes (including cancer) occurring during the observational period will be evaluated additionally. Reported serious adverse events will be validated and analyzed.

Based on experience obtained in previous HRT studies, complex sources of bias and confounding are expected. Multivariate methods will therefore be used to adjust for confounding. This study will emphasize absolute as opposed to relative risk estimates.

Study Design

Observational Model: Cohort, Time Perspective: Prospective




Center for Epidemiology and Health Research


Active, not recruiting


Center for Epidemiology and Health Research, Germany

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:49:10-0400

Clinical Trials [25 Associated Clinical Trials listed on BioPortfolio]

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women

The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.

Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA)...

Vocal in Assessment of Endometrium in Postmenopause

The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding

A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women

This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.

PubMed Articles [7 Associated PubMed Articles listed on BioPortfolio]

Neuroprotective Effects of the Anthocleista Schweinfurthii Gilg. (Loganiaceae) Stem Bark Extract in Postmenopause-Like Model of Ovariectomized Wistar Rats.

Background Estrogen deficiency in postmenopausal period causes severe neuroendocrine changes in brain which influences memory and other nervous functions. Anthocleista schweinfurthii is used tradition...

Thyroid disease in the perimenopause and postmenopause period.

The interpretation of thyroid function tests should be cautiously made during the perimenopause and postmenopause period bearing in mind that physiologic changes do exist in this group of women in ter...

The effect of hydro-alcohol extract of on sexual satisfaction in postmenopause women: A double-blind randomized placebo-controlled trial.

Increasing life expectancy in women and having menstrual problems and hormone-associated complications have led people to use complementary and alternative medicine. In menopause, the reduction in est...

Hormone Therapy During Peri- and Postmenopause.

The recently published 18-year-follow-up of the WHI-study might resolve the long-standing dispute about hormone therapy, possibly reconciling the opposing parties attributing life-threatening risks to...

Activation of PI3K/Akt pathway mediated by estrogen receptors accounts for estrone-induced vascular activation of cGMP signaling.

Estrone (E1) produces remarkable vascular effects, including relaxation, modulation of proliferation, apoptosis and cell adhesion. This study investigated the role of estrogen receptors and endothelia...

Medical and Biotech [MESH] Definitions

The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life.

More From BioPortfolio on "European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)"

Quick Search


Relevant Topics

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial