The first at-home
test to determine when a woman has reached menopause was released to the
public Tuesday by Physicians Laboratories.
The "Menopause
Home Test" was approved by the Food and Drug Administration in January
2001 and is done in the same fashion as the home urine test to determine
pregnancy, said Dr. Aaron Tabor, medical director for Physicians Labs,
a division of Physicians Pharmaceuticals Inc.
As with an at-home
pregnancy test, two lines in the diagnostic window of the test stick indicates
menopause, while just a single line is a negative response.
Tabor said
clinical trials showed the test to be accurate and in agreement 99 percent
of the time with the gold standard blood test for menopause.
In both tests,
the determination of menopause is the level of FSH or Follicle Stimulating
Hormone. The higher the level of FSH -- the lower the level of estrogen
in the body -- which indicates menopause onset.
Menopause,
or change of life, occurs at different ages but 35 is not too young to
start experiencing early signs -- fatigue, mood swings, depression, hot
flashes, difficulty sleeping, severe menstrual periods -- that signal the
advance stage of menopause caused perimenopause.
"Any of these
after age of 35, you have to start thinking, 'Could I be entering into
perimenopause,'" Tabor said, adding at that point a woman should do the
at-home test every six months.
"There is no
set-in-stone time frame when you will enter officially menopause, and that
could happen within months, years," Tabor said.
Menopause is
defined as the absence of menses for 12 consecutive months. The American
Association of Clinical Endocrinologists calls it "a state of hormone deficiency."
While menopause usually
occurs in women between ages 40 to 55, perimenopause and menopause can
occur as early as 35 and as late as 60 years old. The median age
of menopause for American women is 50.5 years. It is associated with adult-onset
ovarian failure, a decrease in estrogen production, discontinuation of
menstruation and rising FSH levels.
The symptoms
of menopause can be treated through a variety of methods, including the
use of birth control pills and hormone replacement therapy. Tabor said
a woman should talk with her doctor once menopause has begun because it
can lead to bone loss, elevated blood pressure and an increased risk of
heart disease.
The test is
being made available only through the company's via a toll-free number
or its Web site, at a cost of $59.95.
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Copyright 2001 by United
Press International.
All rights reserved.
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