But, women taking tibolone had a 2.2 times increased risk of stroke. This increased stroke risk caused the study to be stopped in February 2006, before the trial was complete.
For younger women, tibolone may be a good choice for relieving menopausal symptoms, Cummings said.
"Women who are having menopausal symptoms in their 50s can continue to take tibolone, because it is relatively safe and also does have other benefits, such as a reduction in the risk of fracture and breast cancer," he said.
Cummings noted that tibolone is not available in the United States, although it is available in 90 other countries. "It will not be available in the United States, because the company is not asking the U.S. Food and Drug Administration to approve it," he said.
Tibolone is made by Organon, which is owned by Schering-Plough of Kenilworth, N.J. The company has decided not to try to get tibolone approved in the United States because of the increased risk of stroke, Cummings said.
Dr. Michael Strongin, a gynecologist at Lenox Hill Hospital in New York City, said, "All drugs that are being used for menopausal symptoms all have positives and negatives. The task is to find drugs that don't have problems."
"For the U.S. consumer, it's sort of a moot point," Strongin added. "It [tibolone] is not the magic bullet, but I think it's another drug that could potentially be used if it ever does get FDA approval. My caution would be that it's potentially helpful, but it's not a slam dunk that it's better than what we have been using."
To learn more about hormone replacement therapy, visit the U.S. Women's Health Initiative.
SOURCES: Steven R. Cummings, M.D., California Pacific Medical Cente
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