The Germany-based Bayer Schering Pharma AG is all set to start phase III trials with an innovative patch for female contraception that combines low dosed ethinylestradiol and gestodene. Approximately 3300 women will be enrolled into two global studies to evaluate the contraceptive reliability of the patch starting in May 2009. It is planned to submit the new patch for registration worldwide. First filing is expected in 2012.
"Bayer Schering Pharma is looking forward to progressing to phase-III trials with our novel patch. It will be the smallest, lowest dosed and the only transparent patch for female contraception on the market," said Phil Smits, head of Women's Healthcare at Bayer Schering Pharma. "We are optimistic that these attributes will make it an attractive option for women seeking alternative routes of hormonal contraception."
The patch will be applied once per week, i.e. three patches per cycle (for 21 days) and one week off. The simple handling will make the product convenient to use, and therefore, a good compliance from the user can be anticipated.