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FDA Approved Treatment for Painful Intercourse (Dyspareunia) Due to Menopause
Date:2/27/2013

r women with dyspareunia due to menopause. Osphena demonstrated significant improvements in painful intercourse as well as on the physical changes of the vagina associated with menopause.

Osphena is an estrogen agonist/antagonist with tissue selective effects. Serious risks of estrogen-alone therapy or Osphena can include increased risk of endometrial cancer, stroke, and deep vein thrombosis (DVT). Osphena should be prescribed for the shortest duration consistent with treatment goals for the individual woman. Women considering treatment for dyspareunia are encouraged to discuss the potential risks and benefits of Osphena with their healthcare provider. Please see below for additional Important Safety Information.

For more information about dyspareunia, VVA and Osphena, please visit http://www.WhatIsDyspareunia.com.

Important safety information for osphena™ (ospemifene) tablets:

Boxed warning: endometrial cancer and cardiovascular disorders

Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium osphena has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen therapy. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

The women’s health initiative (WHI) estrogen-alone substudy reported an increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo. Osphena 60 mg
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