Just a few short months ago, in February of this year, the FDA approved a new drug for women for the treatment of pain with sexual intercourse. It is a pill taken by mouth that is NOT an estrogen, but activates the estrogen receptors in the vaginal tissue. This actually then REVERSES the effect of lack of estrogen on these tissues that happen to many women in perimenopause and menopause.
The drug is called Osphena® (the generic name is ospemifene). It is in the general category referred to by doctors as SERM’s – selective estrogen-receptor modulators. This means that it binds to estrogen receptors, and has activating effects on some tissues and blocking effects on other tissues. In the case of Osphena®, it activates the estrogen receptors in vaginal tissue and literally reverses the changes that happen to these tissues due to a lack of estrogen.
Osphena® also stimulates the estrogen receptors in the lining of the uterus, but in the studies conducted for FDA approval in which just over 1,100 women were treated with Osphena®, there were no cases of uterine cancer or pre-cancer. The effect of this medication on estrogen receptors in breast tissue was not studied, but in the women studied there were no reports of breast tenderness and there were no mammographic changes (for example, there was no increase in breast tissue density seen on mammograms before and after being given Osphena®). Estrogen receptors in bone were not studied.
Of the 3 clinical studies done for FDA approval, 2 of them were 12 weeks long, which was enough time for women to report a benefit from the 60 mg dose of Osphena®. The third study was a one-year long follow-up study which showed no statistically significant increase in risk of bad things like stroke or endometrial cancer. There were 9 studies done before the clinical trial phase showing good safety outcomes for this drug (various doses were used, almost 1900 women participated, and just over 400 of these women were followed for one year).
DR. LIZ’S OPINION: At this point, having only just learned about this medication, I am optimistic about the safety profile of Osphena®, and I always welcome more options for women to be able to have an enjoyable sex life. I think because of the similarity between this drug and Evista (raloxifene) – a treatment option for osteoporosis – we will see no harm to women’s bone density, which is extremely important, and maybe it will even prove to be helpful. Also, because the tissue of the base of the bladder is pretty much the same as the cells of the lining of the vagina, I’m looking forward to seeing whether it will help with menopausal bladder problems.
Because of the whacky way our FDA works, even though Osphena® is NOT an estrogen, they required the package insert for Osphena® to carry the black-box warnings about estrogen. If you read my book, you already know that estrogen has actually been shown to lower the risk of breast cancer, but I’ll say more about that another time. Also because of FDA rules, this medication was ONLY approved “for the treatment of moderate to severe dyspareunia [painful intercourse], a symptom of vulvar and vaginal atrophy [thinning], due to menopause.” In other words, your doctor has to specify all this in your medical records or your insurance might not cover it. (In any case, as a new medication I don’t know what kind of coverage it will get.)
Because of doctors’ and women’s current fear of estrogen therapy, I think this will be a good option for women with a family history of breast cancer (and no personal history of breast cancer). I even think it will prove to be a good option for women who themselves have had breast cancer, although it might take doctors a really long time to warm up to that idea.
In the meantime, I’ll keep working to keep you informed of up-to-date information about ways for women to feel their best during perimenopause and menopause!