N/A
Completed N=58,303
European Active Surveillance Study (EURAS)
Source: ClinicalTrials.gov NCT00302848 ↗Enrolled (actual)
58,303
Serious AEs
6.6%
Results posted
Nov 2009
Primary outcomePrimary: Number of Participants With Venous Thromboembolism (VTE) — 26; 25 Participants — p=<0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Venous Thromboembolism (VTE) |
26; 25 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Women starting OC use or women switching OCs
- Women willing to participate in the active surveillance for several years
Exclusion Criteria
- Women who have contraindications for OC use
Data sourced from ClinicalTrials.gov (NCT00302848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.