FDA approves once-weekly combination HT patch: first menopausal TX with levonorgestrel.(News)

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 M Pinkerton, medical director of the Midlife Health Center, University of Virginia, 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.

The new patch will be available by the middle of the month, she said.

Since the publication in 2002 of findings from the Women's Health Initiative (WHI) on oral hormone therapy (HT) 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.