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Fertility Drug May Be New Hot Flash Treatment
Sept. 16, 2009 -- Women suffering from severe postmenopausal hot flashes may get relief from the fertility drug Cetrotide, a small study suggests.
The three women in the study had their lives disrupted by frequent, severe hot flashes, says study leader Hans de Boer, MD, PhD, of Rijnstate Hospital in Arnheim, Netherlands.
One developed symptoms after going off hormone therapy. Another was a breast cancer survivor who underwent treatment with an estrogen-blocking drug. The third had her ovaries removed during successful treatment for endometrial cancer.
"They all responded very well to the treatment," de Boer tells WebMD. "The woman who had breast cancer treatment had a very large number of hot flashes and now has only two a day. She has totally changed. She couldn't live her life before, and now she is a very happy person."
The drug used to treat the women was Cetrotide, a fertility drug. The drug helps control hormones that tell the ovaries when to release an egg. There are receptors for the same hormones in the brain cells that control the body's thermostat.
Cetrotide is given by daily, self-administered, under-the-skin injections. Two of the women in the study eventually needed two daily doses.
Cetrotide isn't cheap. A single dose costs about $124, although prices vary from pharmacy to pharmacy. But de Boer says that if clinical trials find the drug to be a safe and effective treatment for hot flashes, demand may drive the price down.
And clinical trials will be needed. De Boer is quick to note that although his small study is suggestive, only much larger studies can show whether -- and how -- Cetrotide can be used to treat hot flashes.
But so far, the treatment seems safe.
"I have not seen any side effects, and I don't expect them," de Boer says. "It may lower estrogen levels further in postmenopausal women, and this could possibly have a negative effect on bone mass. But I don't think we'll see much of this effect because estrogen levels are already so low in postmenopausal women. And in women treated for breast cancer, it could be an advantage if estrogen levels decline further."
De Boer says he has no financial interest in Cetrotide, although he says he is talking to the drug's manufacturer about supporting a placebo-controlled clinical trial.
Not every woman who goes through menopause suffers from hot flashes. But some women, particularly those thrust into menopause by hormone treatments for breast cancer, may have their lives disrupted by frequent and severe hot flashes.
Hormone therapy helps hot flashes for many women, but not for all who suffer severe symptoms. And many doctors are reluctant to offer hormone therapy because of safety concerns.
It's not clear why hot flashes occur, but a hormone called LHRH (luteinizing hormone-releasing hormone) may be involved. It's thought that LHRH triggers brain cells that control temperature regulation, tricking the body into reacting as though it's too hot. Cetrotide blocks the cellular receptor LHRH uses for cell signaling.
De Boer and colleagues report the findings in the Sept. 17 issue of the New England Journal of Medicine.
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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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