The approval means that Climara Pro is the only combination once-a-week hormone therapy patch approved for the prevention of postmenopausal osteoporosis and the relief of vasomotor symptoms associated with menopause.
Climara Pro was approved by the FDA in November 2003 as a treatment for moderate to severe vasomotor symptoms such as hot flashes and night sweats associated with menopause.
The product was shown to be safe and effective in the prevention of postmenopausal bone loss in a multicenter, placebo-controlled study involving 150 women. During the two-year treatment period, women treated with Climara Pro significantly maintained bone mineral density at the lumbar spine and hip compared to those on placebo.
“While it has long been accepted that estrogen helps maintain bone density following menopause, our studies, and this new indication, solidify the positive effect that Climara Pro has on bones, while helping women manage moderate to severe vasomotor symptoms associated with menopause,” said Dr Paul Korner, executive director of medical affairs for female healthcare at Berlex.