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INAS-SCORE International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens
The primary objective of the study is to assess the risks of short and long-term use of estradiol valerate/dienogest (EV/DNG) and of established oral contraceptives (OCs) in a study population that is representative for the actual users of the individual preparations. This includes an estimate of the absolute risk of rare serious adverse outcomes.
Details
| Lead sponsor | Center for Epidemiology and Health Research, Germany |
|---|---|
| Status | COMPLETED |
| Enrolment | 50203 |
| Start date | 2009-08 |
| Completion | 2017-06 |
Conditions
- Contraception
Primary outcomes
- Venous Thromboembolic Events (VTE) — up to 7 years
- Acute Myocardial Infarction (AMI) — up to 7 years
- Cerebrovascular Accidents (CVA) — up to 7 years
Countries
Germany