Let’s say you’re a woman going through the menopausal transition. You’re experiencing burning and itching in your vagina…you often feel an urgent need to pee…and sex is uncomfortable.

So your physician recommends that you try vaginal estrogen. It’s effective for these issues, and it’s available as a cream, an insert or a ring. Unlike oral hormone therapy, it won’t help with hot flashes, but you’re not particularly bothered by them.

So far, so good. But when you get home and open the package, you see a “black box” warning that you’re at slightly increased risk for heart attacks, strokes, blood clots and breast cancer. Whoa!

Relax. There’s growing evidence that these claims are unwarranted. The latest and largest study to date has found no increased health risk—and even possible benefits—from this form of hormone therapy.

Background: “Genitourinary syndrome of menopause” can include symptoms such as dryness, burning and itching in the genitals…pain while urinating…a feel of urgency when it comes to urination…lack of lubrication (and sometimes pain) during sex…and frequent urinary tract infections. These issues affect as many as 45% of women in the menopausal transition and can last into postmenopause.

One established treatment is low-dose estrogen delivered directly to the problem area via vaginal inserts or ointments—that is, vaginal estrogen. Even though the majority of the estrogen stays where it is needed to do its job, a small amount of estrogen enters the bloodstream and can travel throughout the body. While all the evidence to date has suggested that it’s safe, there hasn’t been a comprehensive study that answered the question—until now.

Study: The Women’s Health Initiative Observational Study began in 1993 and enrolled nearly 100,000 women who were between the ages of 50 to 79 at the start of the study. During the course of the study, questionnaires were sent to the participants every few years to collect information about risk factors and various health conditions, including cancer, blood clots and heart disease.

For this particular analysis, researchers looked at women who used vaginal estrogen and compared them to women who didn’t use any form of hormone therapy. In the end, there were 45,663 women in this analysis—and about 4,200 had used vaginal estrogen. They were followed for an average of 6.4 years.

Results: After adjusting for various risk factors for heart disease, clots and cancer, women who had used vaginal estrogen were not at any higher risk for invasive breast cancer, colorectal cancer, stroke, blood clot or premature death.

Surprising finding: Women who went through “natural” menopause—that is, women who didn’t have a hysterectomy—who used vaginal estrogens were actually at reduced risk for both heart disease and hip fracture compared with those who did not use vaginal estrogens. Whether this is due to low levels of systemic estrogen as a result of the vaginal estrogen therapy or simply a healthy lifestyle in women who choose this method isn’t known.

Bottom line: Vaginal estrogen is effective in treating the genitourinary symptoms of menopause, and this study adds evidence to support its safety.

Most forms of vaginal estrogen won’t help with hot flashes, however. If hot flashes are your issue, talk to your doctor about hormonal and nonhormonal approaches.

Nor is vaginal estrogen the only effective resource for genitourinary issues. Recently, the FDA approved Intrarosa, a DHEA vaginal suppository that helps the body create estrogen in vaginal tissues. There are also many nonhormonal ways to manage vaginal dryness, including natural lubricants. And Kegel exercises are key to treating urinary urgency and overactive bladder.

But if you decide that vaginal estrogen is right for you, rest assured—there’s growing evidence that it’s safe. According to the American College of Obstetricians and Gynecologists, vaginal estrogen is safe even for breast cancer survivors, who are often advised to avoid systemic estrogen.

There’s one exception—Femring, a vaginal ring that has high levels of estrogen. Unlike other vaginal estrogen products, it actually is approved to treat hot flashes. But because of the high levels of estrogen, it likely has systemic effects and is not recommended for women who are breast cancer survivors.

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