Track topics on Twitter Track topics that are important to you
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.
Observational Model: Cohort, Time Perspective: Prospective
Center for Epidemiology and Health Research
Active, not recruiting
Center for Epidemiology and Health Research, Germany
Published on BioPortfolio: 2014-08-27T03:49:10-0400
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).
The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.
To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA)...
The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
To assess the relationship of constipation and diarrhea severity during the menopause transition (MT) with age, MT stage, reproductive biomarkers, stress-related biomarkers, and stress-related percept...
To evaluate severity and pattern of structural and functional changes of vascular wall in early postmenopausal women receiving chronic treatment with a low-dose combination of 17β-estradiol (E2) 1 mg...
Dehydroepiandrosterone (DHEA) is an adrenal steroid hormone that is a precursor of sexual hormones. It is reduced during aging and is strongly associated with insulin resistance and obesity. There is ...
Bone loss in women accelerates during perimenopause, and continues into old age. To-date, there has been little progress made in stratifying fracture risk in premenopausal and early postmenopausal wom...
The progressive decline of the ovarian follicle pool leads to reproductive ageing. The latter is accompanied by age-related disorders, including various types of cancer. In fact, the highest rates of ...
The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life.
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...