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Frequently Asked Questions
What is ospemifene?
Ospemifene (Osphena) is a non-hormonal selective estrogen receptor modulator (SERM) FDA-approved for moderate-to-severe dyspareunia and vaginal dryness due to genitourinary syndrome of menopause (GSM). It exerts estrogen-agonist activity on vaginal epithelium with minimal effect on the breast.
How does it differ from vaginal estrogen?
Ospemifene is a once-daily oral pill with selective tissue action, while vaginal estrogen is applied locally. Both improve GSM symptoms effectively. Ospemifene is useful for women who prefer an oral medication or cannot use vaginal products, but it has systemic effects including a small VTE signal and hot flashes.
Is ospemifene FDA-approved?
Yes. Ospemifene is FDA-approved at 60 mg orally once daily for moderate-to-severe dyspareunia and vaginal dryness due to menopause.
What are the main risks?
The label carries a boxed warning for VTE and a precaution about endometrial cancer (low risk based on trial data). Hot flashes are the most common side effect. Use with caution in women with VTE history or active cancer.
Does ospemifene increase breast cancer risk?
Trial data have not shown an increase in breast cancer; preclinical data suggest a neutral-to-antagonist effect on breast tissue, similar to other SERMs. Long-term human data remain limited.
How long does it take to work?
Improvement in dyspareunia is typically seen within 4 weeks, with maximal benefit by 12 weeks.
Can I get ospemifene without a prescription?
No. Ospemifene is a prescription medication.
How do I find a doctor who prescribes ospemifene?
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