New treatment for postmenopausal sex discomfort approved

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Here is some relief for women experiencing pain during sexual intercourse (dyspareunia), one of the most common problems reported by postmenopausal women. The U.S. Food and Drug Administration has just approved a new drug to treat mild to moderate dyspareunia. Osphena acts like estrogen, making vaginal tissues thicker and less fragile, resulting in a reduction in pain.

Three clinical studies involving almost 2000 postmenopausal women with symptoms of vulvar and vaginal atrophy were used to establish the safety and effectiveness of this drug. Women were assigned to either a placebo or a treatment group. After 12 weeks, those women receiving Osphena reported significant improvement of dyspareunia symptoms.

Warnings about possible serious adverse effects of Osphena include that it may cause thickening of the lining of the uterus which is not normal in menopausal women and state that women should see their doctors if they experience abnormal bleeding a possible sign of endometrial cancer or other conditions. The warnings also indicate an increased risk of thrombotic and hemorrhagic strokes and deep vein thrombosis, although those risks are low compared to the increased risks seen with estrogen-alone therapy.

Common side effects seen during the clinical trials included hot flush/flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating.

ACSH s Dr. Gilbert Ross added, Like other estrogen-receptor modulators, namely raloxifene and tamoxifen, this drug has different actions in different tissues. Thankfully for the large numbers of postmenopausal women suffering from uncomfortable or painful intercourse, this drug seems to improve vaginal atrophy due to menopause, the most common cause of dyspareunia. It does have some toxicities, also common to its chemical relatives.