Berlex's estradiol-levonorgestrel transdermal system (Climara Pro) is now approved for the prevention of postmenopausal osteoporosis in women with an intact uterus.

The patch is applied once weekly and delivers 0.045 mg/day of estradiol and 0.015 mg/day of levonorgestrel. It is the only once-weekly combination patch approved for this indication.

The FDA based the approval of the new indication for estradiol-levonorgestrel transdermal system on data from a 2-year trial in 150 women, which showed that use of the patch was associated with a significant maintenance of bone mineral density at the lumbar spine and hip, compared with placebo.

Estradiol-levonorgestrel transdermal system was previously approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause in women with an intact uterus.