Bayer submits new oral combo contraceptive

Germany's Bayer Schering Pharma AG has submitted for registration the first combined oral contraceptive product based on estradiol and the progestin dienogest to all member states of the European Union. The Netherlands will serve as the reference country for the decentralized procedure towards Europe-wide marketing authorization.

This new oral contraceptive provides estradiol, the same estrogen produced by the female body. According to Bayer Schering, a comparative clinical study showed that its novel combination results in "a good cycle control, comparable to combined oral contraceptives with 20mcg ethinylestradiol." Clinical research also demonstrated that this new oral contraceptive has a less pronounced impact on liver and metabolic parameters compared to the investigated comparators, the firm noted.

"With this submission, we demonstrate our commitment as the worldwide market leader in female contraception to develop innovative oral contraceptives with added health benefits for women," said Phil Smits, head of Women's Healthcare at Bayer Schering Pharma AG. "Our new product is the first oral contraceptive that is based on a bio-identical estrogen. We are absolutely delighted to be the first to have achieved this important milestone in the development of oral contraceptives," he added.