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Vivelle-Dot Now Available In The U.S. For ERT MIAMI, FL -- July 6, 1999 -- Novogyne Pharmaceuticals' estrogen replacement therapy (ERT) patch, Vivelle-Dot(TM) (estradiol transdermal system), is now available in the United States. Vivelle-Dot is the world's smallest ERT patch and comes in four dosage strengths. Vivelle-Dot is 66 percent smaller than the original Vivelle® (estradiol transdermal system) and about 75 percent smaller than the leading ERT patch, yet delivers the same level of estrogen as Vivelle. The latest generation patch utilises Noven Pharmaceuticals' proprietary Dot Matrix(TM) technology to deliver 17-beta estradiol hormone through the skin and directly into the bloodstream. This delivery ensures a sustained, consistent release of estrogen to relieve the vasomotor symptoms of menopause. The new patch, which is applied twice per week to the lower abdomen, is available in four dosage strengths (0.0375, 0.05, 0.075 and 0.10 mg/day) to provide physicians with maximum dosing flexibility. Vivelle-Dot has been shown to be effective in treating moderate-to- severe vasomotor menopausal symptoms such as hot flashes, night sweats and vulval and vaginal atrophy. Some patients taking Vivelle-Dot 0.0375 mg/day may experience a delayed onset of efficacy. Mild headaches have been the most commonly reported systemic adverse event. Clinical trials show a low incidence of skin irritation among users and no erythema has been observed at the application sites after removal for a majority of patients. Systemic adverse events with Vivelle and placebo, respectively, include headache (36 percent versus 30 percent), breast tenderness (4.9 percent versus 1.1 percent) and fluid retention (3.8 percent versus 2.2 percent). Estrogens should not be used in individuals with known or suspected pregnancy, undiagnosed abnormal genital bleeding, breast cancer, estrogen- dependent neoplasia, active thrombophlebitis or thromboembolic disorders, or a documented history of these conditions. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women. E-mail this page to a friend or colleague! To print, use this version