News

New oral contraceptive launched

New product class: Bayer HealthCare employee Ulrike Wolf with the novel contraceptive Qlaira®.

Zoom image

New product class: Bayer HealthCare employee Ulrike Wolf with the novel contraceptive Qlaira®.

Bayer Schering Pharma has started the European roll-out of Qlaira®. The novel oral contraceptive has been available in several European countries, including Germany, since May 2009.

Qlaira® is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. The second component of Qlaira® is the progestin dienogest.

Until now, the only estrogen component used in oral contraceptives worldwide has been ethinylestradiol. Efforts to use estradiol in oral contraception have failed to achieve a satisfactory level of bleeding control. Clinical studies with Qlaira® have shown that the combination of estradiol with the progestin dienogest yields good cycle control. The contraceptive Qlaira® also features a dynamic dosing regimen designed to deliver hormones at the right levels at the right time during the cycle to provide reliable contraception along with good cycle control.

A New Drug Application (NDA) was submitted in the United States in July 2009. There Bayer is seeking approval not only for the contraception indication but also for the treatment of heavy and/or prolonged menstrual bleeding.