Menopausal Symptoms Clinical Trial
Official title:
European Active Surveillance Study of Women Taking HRT
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 continuous combined HRT products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users for up to 8.5 years.
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 continuous combined HRT products. This active surveillance
study will assess pertinent cardiovascular outcomes in new HRT users over a study period of
up to 8.5 years. Also, all other serious adverse events will be reported.
The new drug product under surveillance in the EURAS - HRT study contains the novel
synthetic progestagen drospirenone (DRSP) combined with estradiol.
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 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. As study participants may switch from oral continuous
combined products to other oral or non-oral HRT products the outcomes for these preparation
are recorded too. However, these results represent not the scientific focus of the study.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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