FDA approves once-weekly hormone patch.

The Food and Drug Administration has approved the Climara Pro transdermal patch--the first once-a-week, combined hormone therapy for moderate to severe vasomotor symptoms associated with menopause.

"Patients appreciate the convenience of a once-a-week patch--it's a great advantage," said Dr. JoAnn V. Pinkerton, medical director of the Women's Place, Midlife Health Center, University of Virginia Health System, Charlottesville.

No other menopausal therapy on the U.S. market contains levonorgestrel, a type of progestin. Progestin therapy is indicated for women who have an intact uterus. Levonorgestrel has been used safely in women's health care products for more than 20 years, according to Kimberly Schillace, a spokeswoman for Berlex, the patch's manufacturer.

Since the publication in 2002 of findings from the Women's Health Initiative (WHI) on oral hormone therapy with conjugated equine estrogens (0.625 mg/day) and medroxyprogesterone acetate (2.5 mg/day), there has been concern that high levels of estrogen can be harmful.

Climara Pro delivers a lower dose of estradiol (0.045 mg/day of estradiol and 0.015 mg/day of levonorgestrel) than CombiPatch, the first estrogen and progestin patch on the U.S. market.

"The overall trend is to use the lowest effective dose for the shortest period while symptoms persist," Dr. Pinkerton said.

Two randomized, controlled clinical trials showed that Climara Pro significantly reduced the frequency and severity of hot flashes as early as 1 week into therapy, and that 90% of women experienced an 80% reduction in hot flashes by week 12, according to Berlex Inc., a U.S. affiliate of Schering AG Germany, Berlin.

The transdermal patch is "extremely well tolerated," and few skin problems were reported by patients during clinical trials, said Dr. James A. Simon, who has conducted research on the patch and is on the speakers' bureau for Berlex.