The Revival Menopause Home Test looks and works like those at-home pregnancy and ovulation tests: a few drops of urine on the test stick gives the results.
A small North Carolina company, Physicians Laboratories, began selling the home test this week - but only via telephone or the Internet, not in drugstores. The direct-marketing company also sells soy dietary supplements as a menopause remedy.
The Food and Drug Administration actually approved sale of the menopause home test last January. But it took months for the Canadian inventor, Genua Inc., to license Physicians Laboratories to market the test, said company medical director Dr. Aaron Tabor.
The average age of menopause is about 50, but some women undergo it far younger. It can be difficult for women to tell if they're really entering menopause. Some suffer symptoms such as hot flashes years before their menstrual periods finally end.
Uncertainty about symptoms or missed periods often send women to the doctor for FDA-approved blood tests to tell if menopause really has hit or not.
The new home test measures a follicle-stimulating hormone, or FSH, in women's urine. The amount of FSH in a woman's body fluctuates during her menstrual cycle. As she ages, her ovaries become less responsive to the hormone and gradually secrete less and less estrogen, which in turn affects overall FSH levels. Measuring FSH levels can indicate if menopause has hit or not.
To win FDA approval, the home test had to be as reliable as laboratory tests of menopause. But FDA physicians were not available Tuesday to say when a woman should seek a physician's advice about symptoms instead of relying on a home test.
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