Hello Heather (and everyone else too!)
In 2013, the FDA approved the first pill-based drug (Osphena) for women who experience pain during sex at menopause.
It is taken daily and is designed to treat menopausal symptoms sch as vaginal atrophy that make the vaginal tissue thinner and more fragile, causing pain during sexual intercourse. (Our ovaries stop producing the hormone estrogen at the time of menopause, usually around age 45 or 50.)
Osphena acts like replacement estrogen and makes vaginal tissue thicker and less fragile.
The drug carries a black box warning alerting doctors and patients that Osphena can increase the risk of endometrial cancer, stroke and blood clots. The drug’s prescribing guidelines recommend that it be used for the shortest amount of time possible to achieve patients’ treatment goals.
Common side effects of the drug include hot flashes, vaginal discharge, muscle spasms and excessive sweating.
The FDA approved the drug based on studies involving 1,889 postmenopausal women who were randomly assigned to receive Osphena or placebo (sugar pill). After 12 weeks, women taking the drug had a statistically significant improvement in their symptoms.
Based on the information available to me, Osphena appears to be a drug selectively targeting estrogen-sensitive tissue, and thus not necessarily significantly different from topical estrogen in its various forms. Note the black box warning and warning to use for as short a period of time as possible, which may not make it a good choice to be used on its own for vaginal atrophy, a more appropriate diagnosis than dyspareunia, given that dyspareunia can be caused by many other things, including high tone pelvic floor dysfunction, vaginismus, vulvodynia, and vulvar skin disorders, none of which would be appropriately treated by this.
I hope this information is useful.
Blessings,
Dr. Anitahoffer
