It’s a common problem among post-menopausal women — painful sexual intercourse due to thinner, drier, more fragile vaginal tissue, according to AARP.org.
Known as dyspareunia, this condition is associated with declining levels of estrogen during menopause, which leads to thinner, drier, more fragile vaginal tissues, wrote WebMD.
Mayo Clinic said that it often results in persistent or recurrent genital pain just before, during or after intercourse.
Now, older women suffering from painful intercourse have a new treatment approved by the U.S. Food and Drug Administration (FDA), reported Boston Globe.
Osphena, known chemically as ospemifene, is a pill that mimics the effects of estrogen on vaginal tissues, making them thicker and less fragile. This results in a reduction of painful intercourse, wrote HuffingtonPost.com.
Although there are estrogen creams and suppositories that help women with vaginal tearing and dryness, Osphena – taken once daily with food – is less messy and not estrogen-base, wrote AARP.org.
The safety and effectiveness of Osphena was established in three clinical studies involving nearly 1,900 postmenopausal women with signs of thinner, drier, more fragile vaginal tissues, said MedicineNet.com.
After 12 weeks of treatment, results from the first two studies showed an improvement in sexual pain among women who took Osphena compared with those who took a placebo, wrote WebMD.
It’s important to note that Osphena comes with a black box warning to alert women that the pill could cause the uterine lining to thicken. The risk of endometrial cancer may increase, said Boston Globe.
WebMD said that the black box warning also notes that about one woman in a thousand faces a risk of strokes caused by blood clot or bleeding in the brain. There is also risk for deep vein thrombosis, in about 1.45 women in a thousand.
Boston Globe reported that since the new pill hasn’t been compared to older products in head-to-head trials, it’s not known whether it’s safer or more effective.
The pill also hasn’t been tested on women who have had breast cancer, so they’re warned not to take it. WebMD reported that or these reasons, the FDA advised that the drug “should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.”
Common side effects include hot flashes, vaginal discharge, muscle spasms and excessive sweating, wrote HuffingtonPost.com.
Gynecologist David Portman, M.D., of the Columbus Center for Women’s Health Research, was the lead researcher in Osphena’s trials. He told AARP.org that women enrolled in the trials reported benefits by the fourth week on the drug, though he added “it’s not known when or if symptoms recur after discontinuing therapy.”
Shionogi Inc., the maker of Osphena, told the Los Angeles Times that the drug is expected to be available in the United States in June, but no price has been set, said AARP.org.
Sources:
Brooks, Megan. "FDA OKs Drug for Painful Sex in Older Women." Women's Health Center: Information on Women's Wellness, Nutrition, Fitness, Intimate Questions, and Weight Loss. N.p., n.d. Web. 13 Mar. 2013.
http://women.webmd.com/news/20130227/fda-drug-painful-sex-older-women?ecd=wnl_sxr_030213&ctr=wnl-sxr-030213_promo_1&mb
"FDA Approves Drug for Older Women Experiencing Painful Sex." MedicineNet.com. MedicineNet, Inc., n.d. Web. 12 Mar. 2013.
http://www.medicinenet.com/script/main/art.asp?articlekey=168120
"FDA approves Osphena for postmenopausal women experiencing pain during sex." U S Food and Drug Administration Home Page. N.p., n.d. Web. 13 Mar. 2013.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm341128.htm
Kotz, Deborah. "Painful sex? Menopausal women have a new pill for treatment - Boston.com." Boston.com - Boston, MA news, breaking news, sports, video. N.p., n.d. Web. 13 Mar. 2013.
http://www.boston.com/dailydose/2013/02/28/painful-sex-menopausal-women-have-new-pill-for-treatment/cjRNOFYPO1mbeLcMcXckaK/story.html
"Osphena, Drug For Treating Sexual Pain In Women, Approved By FDA." Breaking News and Opinion on The Huffington Post. N.p., n.d. Web. 13 Mar. 2013.
http://www.huffingtonpost.com/2013/02/26/osphena-sexual-pail-drug-fda-approved_n_2767169.html
"Painful intercourse (dyspareunia) - MayoClinic.com." Mayo Clinic. N.p., n.d. Web. 13 Mar. 2013.
http://www.mayoclinic.com/health/painful-intercourse/DS01044
Sagon, Candy. "New Drug for Painful Sex in Older Women." AARP.org. AARP, n.d. Web. 12 Mar. 2013.
http://blog.aarp.org/2013/03/01/new-drug-for-painful-sex-in-older-women
Reviewed March 14, 2013
by Michele Blacksberg RN
Edited by Jody Smith