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The European Active Surveillance Study on OC Prescribing Practice, Benefits and Safety (EURAS)
EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. The objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established OCs, and specifically the incidence of thromboembolic events.
Details
| Lead sponsor | Center for Epidemiology and Health Research, Germany |
|---|---|
| Status | COMPLETED |
| Enrolment | 59510 |
| Start date | 2000-11 |
| Completion | 2005-12 |
Conditions
- Contraception
Interventions
- Drospirenone
- Levonorgestrel
- Other progestin containing oral contraceptive
Primary outcomes
- Number of Participants With Venous Thromboembolism (VTE) — 1.5 to 5 years
Countries
Germany