Women who are considering hormone therapy after menopause may soon have a new pill option that is identical to naturally produced human hormones and rigorously scientifically tested and approved by the FDA.

And that would be a first.

Background: Most women who want to take hormone therapy to help manage menopausal symptoms such as hot flashes need both estrogen and progesterone. (The exception—a woman who’s had her uterus removed, who may safely take just estrogen.) The most common prescription option by far is Premarin, a drug that includes hormones that have many of the same effects as human hormones but that are not identical to human hormones.

But many women—and their doctors—would like to have an FDA-approved option for bioidentical hormone therapy. The term “bioidentical” refers to forms of estrogen and progesterone that have the same molecular structure as human hormones. While hotly debated, there is evidence that for some women these bioidenticals don’t carry some of the health risks, such as increased breast cancer risk, as nonbioidentical hormone therapy.

There are bioidenticals available now, including custom-compounded bioidenticals, which are not subject to FDA oversight…FDA-approved bioidentical transdermal estrogen, which is delivered through the skin…and an FDA-approved bioidentical oral progesterone. There has never been a medication that combines bioidentical estrogen and progesterone in a single capsule. But now one drug in development, temporarily dubbed TX-001HR, is a candidate to be the first to get FDA approval—which would be welcomed by a lot of women.

Study: TX-001HR was studied in a double-blind, placebo-controlled trial of 1,835 post-menopausal women. One part of the study looked at its effectiveness in women with frequent hot flash symptoms—at least seven hot flashes a day or 50 a week—over 12 weeks. The other part looked at safety in a larger group of women who took the drug for one year.

Results: At the end of the study, the symptomatic women who had taken TX-001HR reported fewer and less severe hot flashes than the women who were given a placebo. In the women who took TX-001HR for one year, there were no worrisome health effects, and side effects—such as headaches, breast tenderness—were rare.

Bottom line: These results were presented at the annual meeting of the Endocrine Society, so they haven’t been published in a peer-reviewed journal yet. Plus, like many drug trials, they were sponsored by the manufacturer. But the results suggest that the era of FDA-approved bioidentical oral hormone therapy in a single capsule may not be far off.

In the meantime, if you want to go the bioidentical route, talk to your doctor about the many current bioidentical options—such as the combination of an estrogen patch and a progesterone pill—that are available now. If you’re looking for nondrug therapies, see Bottom Line’s article, “No More Hot Flashes!…and No Hormones Needed.”

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