November 25, 2003

ST. LOUIS (MD Consult) – On November 24, 2003, Germany-based Schering AG announced it had received approval from the U.S. Food and Drug Administration (FDA) to market Climara Pro (estradiol/levonorgestrel transdermal system) for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats. According to a statement from Schering, Climara Pro, a thin, translucent patch, is the first once-a-week combined hormone therapy approved in the United States.

“Hormone treatment is one of the most effective ways to alleviate menopausal symptoms,” said Dr. Philip Smits, Head of Schering AG’s Gynecology & Andrology division.

Climara Pro is a transdermal hormone therapy (HT) that uses levonorgestrel, a progestin that has been used worldwide in a variety of women’s health care products for more than 20 years with millions of patient-years of experience. This patch also contains estradiol, an estrogen that is identical to the estrogen a woman’s body produces before menopause. Transdermal (patch) technology allows for continuous delivery of hormones at doses much lower than in pills. Climara Pro delivers 0.015 mg/d of levonorgestrel and 0.045 mg/d of estradiol. Estradiol is the most active estrogen produced by the ovary.

Climara Pro is indicated for use by women with an intact uterus, whereas Climara—Schering’s once-a-week estrogen-only patch—is appropriate for women who have had a hysterectomy.

Climara Pro is expected to be available in January 2004.