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

us Thromboembolism: In the WHI estrogen-alone substudy, the risk of VTE (DVT and PE) was increased for women receiving CE 0.625 mg alone compared to placebo (30 vs. 22 per 10,000 women-years), although only increased risk of DVT reached statistical significance (23 vs. 15 per 10,000 women- years). The increase in VTE risk was demonstrated during the first 2 years. Incidence rate of DVT was 1.45 Osphena vs. 1.04 placebo per thousand women. Should a VTE occur or be suspected, Osphena should be discontinued immediately. Osphena should be discontinued at least 4 to 6 weeks before surgery with increased risk of thromboembolism or during periods of prolonged immobilization.

Malignant Neoplasms

Endometrial Cancer: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen therapy. The risk appears dependent on duration of treatment and estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. However, studies suggest a possible increased risk for breast cancer in patients receiving estrogen plus progestin therapy.

  •     Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium Osphena has agonistic effects. In Osphena clinical trials, no cases of endometrial cancer were seen with exposure up to 52 weeks. There was a single case of simple hyperplasia without atypia. Endometrial thickening equal to 5mm or greater was reported at a rate of 60.1 Osphena vs. 21.2 placebo per 1000 women. Uterine polyps occurred at an incidence of 5.9 Osphena vs. 1.8 placebo per 1000 women, and any type of proliferative endometrium (weakly plus active plus disordered) was 86.1 Osphena vs. 13.3 placebo per 1000 women.

  •     Adequate diagnostic measures, including directed or random endometrial sampling when indicat
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