Oral Contraceptive Yasmin (Drospirenone/Ethinyl Estradiol) Approved in Canada
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Oral Contraceptive Yasmin (Drospirenone/Ethinyl Estradiol) Approved in Canada

MONTREAL, QC -- January 12, 2005 -- Good news for Canadian women, Berlex Canada Inc. has announced the approval of Yasmin® (drospirenone and ethinyl estradiol) tablets, one of the leading birth control pills in the world. This new, low-dose oral contraceptive is the first and only to contain the unique progestin, drospirenone, which has antimineralocorticoid activity.

"Yasmin represents a true advance when it comes to oral contraceptives. Among the 20 or more brands of birth control pills currently available in Canada, Yasmin is the only one that contains the unique progestin, drospirenone, which has antimineralocorticoid activity similar to the natural hormone progesterone and is not derived from the male hormone testosterone," said Dr. Albert Yuzpe, Co-Director of the Genesis Fertility Centre, Vancouver, BC. "This activity causes moderately increased sodium and water excretion which is an outstanding characteristic not described for any other synthetic progestin and is devoid of any of the male hormone related effects."

In 2001, 106,418 abortions were performed in Canada. Fifty per cent of these abortions were performed on women younger than age 25.(1) Over 40 per cent of unplanned pregnancies in Canada may be the result of poor compliance to oral contraceptives.(2) In fact, according to a study entitled, Oral contraceptive discontinuation: A prospective evaluation of frequency and reasons, 46 per cent of women stated side effects as their reason for discontinuing.(3)

When women discontinue the use of oral contraceptives, 42 per cent do so without consulting their health-care provider, 19 per cent discontinue without selecting another contraceptive method and 69 per cent choose a less effective contraceptive method.(3)

"Thousands of unintended pregnancies occur each year in this country because women stop taking their birth control pills," explained Dr. Yuzpe. "Women are often dissatisfied with the choices currently available to them and this is often due to side effects. An oral contraceptive that makes birth control more acceptable for more women in this country is not only important, but necessary progress."

According to a study published in The European Journal of Contraception and Reproductive Health Care, which assessed the contraceptive reliability, cycle control and tolerability of Yasmin compared to an established oral contraceptive, Yasmin provided effective oral contraception, excellent cycle control and tolerability.(4)

Data Demonstrates Safety, Efficacy and Tolerability
Trials found that Yasmin offers a low rate of spotting and breakthrough bleeding. Yasmin proved to be more than 99 per cent effective in preventing pregnancy, with only one pregnancy occurring in 3,201 cycles of 326 Yasmin users. Women who participated in clinical studies tolerated Yasmin very well, with only six per cent discontinuing use due to side effects.(5)

The launch of Yasmin continues in the tradition of Berlex's parent company, Schering AG, which was the first company to introduce oral contraceptives in the European market 40 years ago. Approved in the United States in 2001, more than five million women worldwide have taken Yasmin.

Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Women who use oral contraceptives are strongly advised not to smoke.

References:

1. http://www.statcan.ca
2. http://www.cbctrust.com
3. Rosenberg MJ et al. Am J Gynecol 1998;179(3Pt 1):577-82
4. The European Journal of Contraception and Reproductive Health Care 2000;5:124-134.
5. Berlex data on file

SOURCE: Berlex Canada

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