International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)

NCT00335257 COMPLETED Results posted

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.

Details

Lead sponsor	Center for Epidemiology and Health Research, Germany
Status	COMPLETED
Enrolment	85109
Start date	2005-08
Completion	2013-03

Conditions

• Contraception

Primary outcomes

• Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs — 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 — 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.

Countries

Germany