Information from the Nurses' Health Study indicated that the combination of estrogen and androgen used to treat hypoandrogenism could increase breast cancer risk. However, other studies indicated androgens may decrease breast cancer risk. Follow-up studies on the Women's Health Initiative found women who received estrogen and no progestogen showed a significant decrease in cardiovascular disease (CVD) and breast cancer. This has caused a reconsideration of androgens added to estrogens. Still, the FDA requires demonstration of CVD and breast cancer safety for any product containing androgens or estrogen plus an androgen; that has not been done.
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