International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens (INAS-SCORE)
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|ClinicalTrials.gov Identifier: NCT01009684|
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : June 17, 2019
|Condition or disease|
During the development of oral contraceptives (OCs) over the last decades, ethinyl-estradiol (EE) has been reduced under the hypothesis that lower EE doses lead to a better safety profile and specifically to a lower venous thromboembolism (VTE) incidence. However, the reduction of the EE dose led to a less favorable bleeding control.
Though EE has been utilized within numerous OCs, efforts have been made to utilize estradiol (E2) and estradiol valerate (EV) which have lower impact on the hepatic system and subsequently on hemostatic parameters. Bayer Schering Pharma has developed a new EV based OC in a dosing regimen that combines both reliable contraception and acceptable bleeding profile.
The INAS-SCORE study was designed as an international, prospective, controlled, non-interventional cohort study. The study was started in Europe and was extended to the US after the launch of the new regimen. New users of an OC (starters or switchers) are accrued by a network of prescribing physicians. Even in the event of high drop-out rates, a 3 to 5-year follow-up of 50,000 women should be sufficient to document about 150,000 women-years. Baseline and follow-up information are collected via a self-administered questionnaire. All self-reported clinical outcomes of interest will be validated via health care professionals. Classification of reported outcomes as "confirmed" or "unconfirmed" will be checked via blinded, independent adjudication. A multifaceted 4-level follow-up procedure proved to ensure low loss to follow-up rates.
The main clinical outcomes of interest for the short and long-term follow-up are cardiovascular events, primarily deep venous thrombosis, pulmonary embolism, acute myocardial infarction, and cerebrovascular accidents.
Data analysis will be based on life-table methods. All analyses will make allowance for confounding, using multivariate techniques such as Cox regression.
Follow-up was initially expected to last until 2014 for the United States and Europe. However, the European regulatory authorities were concerned about the low proportion of Qlaira users in the United States and requested that the primary analysis should be based on the European study arm only. However, this reduction in sample size results in a reduction of the statistical power.
Therefore it was agreed upon with the European regulatory authorities to extend the follow-up period in Europe till 2016. This will ensure that the statistical power in the European study arm will be as high as the originally planned power for the complete study population (European and US study population combined). The total exposure in Europe will be sufficient to exclude a twofold risk of VTE and a threefold risk of ATE for Qlaira compared to 'Other COCs'.
|Study Type :||Observational|
|Actual Enrollment :||50203 participants|
|Official Title:||INAS-SCORE International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||June 2017|
Users of the oral contraceptive containing Dienogest and Estradiol valerate
Users of oral contraceptives (OCs) containing other progestins and estrogens
- Venous Thromboembolic Events (VTE) [ Time Frame: up to 7 years ]
- Acute Myocardial Infarction (AMI) [ Time Frame: up to 7 years ]
- Cerebrovascular Accidents (CVA) [ Time Frame: up to 7 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009684
|Berlin Center for Epidemiology and Health Research|
|Berlin, Germany, 10115|
|Principal Investigator:||Klaas Heinemann, PhD, MD, MSc||Berlin Center for Epidemiology and Health Research|