MAPLE GROVE, Minn., May 5 Medical specialists from around
the country will gather this week to discuss the latest research in obstetrics
and gynecology, and menopause and estrogen therapy will be among the
information presented.
"Estrogen therapy continues to be the gold standard for the management of
hot flashes, the most common physical sign of menopause," said Dr. Ricki
Pollycove, fellow, American College of Obstetrics and Gynecology and clinical
faculty member, University of California, San Francisco. "However, because of
misconceptions that still exist today due to the influx of conflicting
information that has emerged since the Women's Health Initiative Study, women
may not be aware that advances in low-dose hormone therapies exist."
In June 2007, the U.S. Food and Drug Administration (FDA) approved
Divigel(R) (estradiol gel) 0.1 percent, the lowest approved dose of estradiol
available for the treatment of moderate to severe hot flashes associated with
menopause. Guidelines from the North American Menopause Society (NAMS)
indicate that estrogen hormone therapy should be used at the lowest effective
dose for the shortest amount of time.
"Transdermal estrogen therapies, such as Divigel(R), are emerging as an
effective and safe mode of treatment," said Dr. Pollycove.
The estrogen in Divigel(R) is derived from plant sources and is
bioidentical to the primary estrogen produced by a woman's ovaries before
menopause. Certain older oral estrogen therapies contain conjugated estrogens
derived from the urine of pregnant mares. Divigel(R) is a quick-drying gel
that is odorless when dry, and is available in convenient, individual-use
packets. One packet of gel is applied daily to an area that measures
approximately 5 x 7 inches on the thigh, the smallest application area
compared to all other available gel or lotion estrogen products. After the
gel is applied, it absorbs directly into the bloodstream without having to
pass through the liver. Divigel(R) also offers dosing flexibility with three
different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and 1.0 mg
estradiol/day) to individualize treatment for each woman.
Important Safety Information for Patients
The following are not all the possible risks for Divigel(R). Please read
the full Patient Information leaflet and talk to your healthcare provider.
Estrogens increase the chance of getting cancer of the uterus. 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).
Your healthcare provider should check any unusual vaginal bleeding to find out
the cause. In general, the addition of a progestin is recommended for women
with a uterus to reduce the chance of getting cancer of the uterus.
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 chance of getting heart attacks, strokes, breast
cancer, and blood clots.
Do not use estrogens, with or without progestins, to prevent dementia.
Using estrogens, with or without progestins, may increase your risk of
dementia.
Do not use estrogen products, including Divigel(R), if you have unusual
vaginal bleeding, currently have or have had certain cancers, had a stroke or
heart attack in the past year, currently have or have had blood clots,
currently have or have had liver problems, are allergic to any Divigel(R)
ingredients, or think you may be pregnant.
The most common side effects for all estrogen products are headache,
breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps
and bloating, nausea and vomiting, and hair loss. Less common but serious
side effects include breast cancer, cancer of the uterus, stroke, heart
attack, blood clots, dementia, gallbladder disease and
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