Ignite Creation Date:
2024-05-05 @ 9:59 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01009684
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2009-11-06
Brief Title:
International Active Surveillance Study - Safety of Contraceptives Role of Estrogens
Sponsor:
Center for Epidemiology and Health Research Germany
Organization:
Center for Epidemiology and Health Research Germany
Study Overview
Official Title:
INAS-SCORE International Active Surveillance Study - Safety of Contraceptives Role of Estrogens
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INAS-SCORE
Brief Summary:
The primary objective of the study is to assess the risks of short and long-term use of estradiol valeratedienogest EVDNG 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
Detailed Description:
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 50000 women should be sufficient to document about 150000 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
Study amendment
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
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 50000 women should be sufficient to document about 150000 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
Study amendment
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None