Brand Name: Osphena
Generic Name: ospemifene
Medication Class: Selective Estrogen Receptor Modulator
Manufacturer: Shinogi Inc
FDA Approval Date: February 2013
What is Osphena and its mechanism of action
Estrogen is needed for vaginal lubrication and to increase the vaginal wall. Menopause causes a significant reduction in estrogen and changes in the vaginal wall that can result in painful sex (dyspareunia). Osphena binds to estrogen receptors and mimics the action of estrogen in some tissues or blocks the action of estrogen in other tissues Osphena works like estrogen in the lining of the uterus (womb).
What does Osphena treat
Osphena is an oral prescription medication used for the treatment of painful sexual intercourse (dyspareunia) resulting from changes in and around the vagina due to menopause.
How effective is Osphena
The effectiveness and safety of Osphena on moderate to severe symptoms of painful sexual intercourse in postmenopausal women were examined in two 12-week efficacy trials and one 52-week long-term safety trial. A total of 787 women received placebo (sugar pill) while 1102 women received 60 mg Osphena.
In the 1st and 2nd study, women who were treated with Osphena compared to placebo demonstrated significant relief in moderate to severe most bothersome symptom of painful sexual intercourse (for example, pain, vaginal dryness, vaginal irritation/itching). Also, a laboratory test showed improvement in the wall of the vagina for the women who took Osphena.
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