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

November 13, 2014 updated by: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

30597

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Center for Epidemiology and Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 40 or more years using HRT

Description

Inclusion Criteria:

  • All women aged 40 or more years who started use of a new oral HRT at the time of inclusion in the study

Exclusion Criteria:

  • Women who do not consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
New users of oral continuous combined HRT containing drospirenone
2
New users of oral continuous combined HRT containing other progestagens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)
Time Frame: within 8.5 years
Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
within 8.5 years
Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)
Time Frame: within 8.5 years
Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
within 8.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Collaborators

Bayer

Investigators

  • Principal Investigator: Juergen Dinger, MD, PhD, ZEG, Invalidenstrasse 115, 10115 Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 1, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZEG 2000_3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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