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Non-estrogen Option for Menopause
May 23, 2008 -- New research results show that a non-estrogen drug called Ophena significantly improves symptoms of vaginal dryness and painful intercourse in postmenopausal women, raising hopes of an alterative to estrogen replacement therapy.
Vaginal dryness and painful intercourse, or dyspareunia, are two common symptoms of postmenopausal vulvovaginal atrophy -- thinning of the tissue and lining of the vulva and vagina. It affects up to 40% of postmenopausal women in the U.S.
"For millions of postmenopausal women, the symptoms of vulvovaginal atrophy represent a serious health issue that can have a profound negative impact on quality of life," James A. Simon, MD, CCD, FACOG, clinical professor of obstetrics and gynecology at George Washington University, says in a news release.
Over-the-counter non-hormonal lubricants and moisturizers are available to help with symptoms, but the most effective treatments for vulvovaginal atrophy contain the hormone estrogen. Estrogen replacement therapy has been linked to an increased risk of breast cancer, heart disease, and stroke.
Ophena is a type of drug called a selective estrogen receptor modulator (SERM). Pivotal clinical trial results presented this week at the 12th World Congress on the Menopause in Madrid, Spain, show that women who took Ophena tablets for 12 weeks had significant improvements in symptom scores of vaginal dryness and painful intercourse. The study involved 826 postmenopausal women at 80 different medical centers across the U.S. who were randomly assigned to one of two doses of Ophena or a placebo.
"These study results indicate that Ophena has the potential to be the first non-estrogen treatment option that provides a clear clinical benefit. We are working to advance the development program for Ophena to make this important therapy available to all women who would benefit from it," Robert Zerbe, MD, president and chief executive officer of QuatRx, says in the news release.
The researchers say the drug appears to be safe and generally well tolerated.
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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