Like Climara® (estradiol transdermal system), Berlex's once-a-week estrogen-only patch, Climara Pro delivers the hormones continuously and directly through the skin, with the benefits of unique 3M Drug Delivery Systems technology. With the addition of levonorgestrel, Climara Pro is indicated for use by women with an intact uterus, whereas Climara is appropriate for women who have had a hysterectomy.
Data Demonstrate Safety, Efficacy and Tolerability
Two well-controlled, randomized clinical trials showed that Climara Pro rapidly and effectively controlled menopausal symptoms. For many patients, the frequency and severity of hot flashes was significantly reduced as early as week one, and 90 percent of women experienced an 80 percent reduction in hot flash frequency by week 12.
As a transdermal patch, Climara Pro has a favorable side effect profile, with very low rates of nausea and gastrointestinal complaints that are commonly associated with oral hormonal treatments. Clinical trial participants using Climara Pro also reported a low skin irritation rate, no effect on body weight and a bleeding profile comparable to other hormone therapy. Trials also showed a high level of compliance and a low discontinuation rate due to application-site irritation.
Transdermal delivery avoids first-pass effects through the liver during absorption, which may help avoid drug-to-drug interactions with other products metabolized by the liver. In addition, transdermal hormone therapy, unlike oral therapy, does not increase triglycerides or sex hormone binding globulin (SHBG).
Estrogen/progestin combinations should not be used by women with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, thromboembolic disorders or stroke, liver dysfunction or disease, or any known hypersensitivity to estrogen, progestin or any Climara Pro t
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Contact: Kim Schillace, Berlex Laboratories
kimberly_schillace@berlex.com
973-487-2461
Porter Novelli
24-Nov-2003