International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
|ClinicalTrials.gov Identifier: NCT00335257|
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : November 18, 2014
Last Update Posted : August 7, 2019
|Condition or disease|
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 drospirenone/ethinylestradiol 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.
|Study Type :||Observational|
|Actual Enrollment :||85109 participants|
|Official Title:||International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
Users of OCs containing DRSP
Users of OCs containing other progestins
- Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs [ Time Frame: Within 60 months ]Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.
- Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs [ Time Frame: Within 60 months ]Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335257
|Center for Epidemiology and Health Research|
|Berlin, Germany, 10115|
|Principal Investigator:||Juergen C Dinger, MD, PhD||Center for Epidemiology and Health Research, Berlin, Germany|