• Thromboembolic events [ Designated as safety issue: Yes ]
  

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. The study investigates the 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.

This 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 and will be extended to several European countries based on registration and launch status of the 24-day regimen. New users of an OC (starters or switchers) 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.

Women using oral contraceptives

Inclusion Criteria:

• Women starting OC use or women switching OCs
• Women willing to participate in the active surveillance for several years
• Woman 18 years of age or older

Exclusion Criteria:

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