The FDA has approved (estradiol/levonorgestrel) Climara Pro transdermal system for the alleviation of menopausal symptoms. Climara Pro is the first once-a-week combined hormone replacement therapy (HRT) for the relief of moderate-to-severe vasomotor symptoms associated with menopause. Climara Pro delivers 0.015 mg/d levonorgestrel and 0.045 mg/d of estradiol. The new product is indicated for use by women with an intact uterus.
In clinical trials, Climara Pro rapidly and effectively controlled menopausal symptoms. For many patients, the frequency and severity of hot flashes was significantly reduced by as early as week 1, and 90% of women experienced an 80% reduction in hot flash frequency by week 12. Climara Pro has a favorable side-effect profile, with very low rates of nausea and gastrointestinal complaints commonly associated with oral hormonal treatments. In clinical trials, women using Climara Pro reported low rates of skin irritation, no effect on body weight, and a bleeding profile comparable to other hormone therapy.