The FINANCIAL -- Bayer HealthCare has successfully concluded the decentralized European registration procedure for its new transparent low dose contraceptive patch (gestodene/ethinylestradiol). The Health Authorities of the EU Member States will now grant national approvals for the product, according to Bayer AG.
“The new contraceptive patch will provide women with an additional choice of a low dose contraceptive,” said Dr. Jörg Möller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
The contraceptive transdermal patch is small, round and transparent and contains 2.1 mg gestodene and 550 micrograms ethinylestradiol. Each transdermal patch releases 60 micrograms gestodene per 24 hours and 13 micrograms ethinylestradiol per 24 hours. It is applied once a week either to the abdomen, buttocks or outer upper arm where it delivers a steady, continuous dose of hormones over the seven day application period. The systemic exposure is equal to oral doses as observed after daily administration of a combined oral contraceptive containing 60 micrograms gestodene and 20 micrograms ethinylestradiol. Each patch is replaced after seven days, and after three weeks, there is a hormone-free week.
The data from clinical studies, including 4,200 women worldwide, show that the new low dose contraceptive patch is an efficacious contraceptive with a good safety profile, according to Bayer AG.