Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335257
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2006-06-08
Brief Title:
International Active Surveillance Study of Women Taking Oral Contraceptives INAS-OC
Sponsor:
Center for Epidemiology and Health Research Germany
Organization:
Center for Epidemiology and Health Research Germany
Study Overview
Official Title:
International Active Surveillance Study of Women Taking Oral Contraceptives INAS OC
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations
Detailed Description:
Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception This study investigates the risks of short and long-term use of a 24-day regimen of drospirenoneethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations
INAS-OC is a prospective controlled non-interventional cohort study with two study arms OCs containing drospirenone and OCs containing any other progestogen The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen New users of an OC starters switchers without a pill intake break and recurrent users with a pill intake break same or different OC are accrued by a network of prescribing physicians Baseline and follow-up information are collected via a self-administered questionnaire Data analysis will be based on life-table methods comparing the cohorts All analyses will make allowance for confounding using methods that will include multivariate techniques such as Cox regression
INAS-OC is a prospective controlled non-interventional cohort study with two study arms OCs containing drospirenone and OCs containing any other progestogen The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen New users of an OC starters switchers without a pill intake break and recurrent users with a pill intake break same or different OC are accrued by a network of prescribing physicians Baseline and follow-up information are collected via a self-administered questionnaire Data analysis will be based on life-table methods comparing the cohorts All analyses will make allowance for confounding using methods that will include multivariate techniques such as Cox regression
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