Q: Do I need a moisturizer or estrogen?

When women in my practice have vaginal dryness or atrophy, I typically start by recommending a vaginal moisturizer. The key is to be faithful, using the moisturizer at least two times each week. Yes is the most popular vaginal moisturizer at MiddlesexMD; the fact that it's available in pre-filled applicators is definitely a plus for women who don't like the mess of other options!

If the dryness or atrophy is not effectively managed with a moisturizer (which can happen over time), then I add a vaginal (localized) estrogen product.

I should also mention that a new oral medication for vaginal dryness or pain was approved by the FDA this summer. Non-hormonal, it's called Osphena and is available by prescription. Because it's oral, there's no mess! But you do need to make the consistent commitment, again, to regular use.

Q: Can low-dose hormone therapy affect libido?

Overall, estrogen is helpful to libido and sexual desire. Oral (systemic) estrogen can have the unintended effect of decreasing testosterone, which is linked to libido in women as well as men. The reason is complicated, but has to do with liver metabolism and a binding protein that reduces circulating testosterone.

The approach I take with patients is to use non-oral, transdermal (systemic) estrogen, which bypasses the liver and therefore doesn't affect testosterone levels. I've had patients who couldn't experience orgasm on oral estrogen but could with non-oral estrogen.

And for some women, I do consider adding testosterone. There isn't a product for women, so I use a very low level of male testosterone "off-label" and then monitor blood levels during use. Sometimes, as an alternative, Wellbutrin (buproprion), an anti-depressant, helps restore libido by affecting the neurotransmitter dopamine.

I'm afraid we women are complicated! There are, though, a number of options to experiment with until you've achieved the sex life that makes you happy.

Q: What's the link between estrogen and dementia?

I suspect you've been reading the fine print on an advertisement or packaging for one of the estrogen products—for which I congratulate you! It's good to learn as much as you can about your treatment or options.

The mention of dementia is part of the "class labeling" required by the Food and Drug Administration since the Women's Health Initiative in 2002. Even some non-estrogen products in this class receive the same labeling.

In one WHI study, there was a slight increase in dementia for women who used hormone therapy, but it's important to remember that the women entering the study averaged 64 years of age. Additional studies have not replicated those results. It's also worth noting that post-menopausal women have a greater risk than men of developing Alzheimer disease; estrogen has a role in protecting the brain and its function.

For anyone considering hormone therapy, her age and the age at which she entered menopause are critical considerations for heart and brain health. And, as I've said before, every woman, in consultation with her knowledgeable menopause care provider, must weigh the benefits and the risks of hormone therapy for her specific quality of life.

Q: What's with weight gain and menopause?

This is a common question; unfortunately, it’s complicated to answer. First let me say that while I know weight gain affects many women’s sense of being desirable, what I read and my own informal research suggests it’s rarely an issue for their partners (some of whom are, in fact, oblivious—in a good way—and just as attracted as ever).

There does seem to be a physiologic drive to deposit fat during the menopause transition. The theory is that fat produces estrogen (estrone—a relatively weak estrogen), so in the presence of impending organ failure (menopause) and loss of estrogen from the ovaries (estradiol-the major, more important estrogen) that will occur, the body does its defensive thing: It deposits fat, really efficiently and effectively.

Unfortunately, estrone doesn’t provide many favorable effects. The major location for depositing fat is the midsection. Women who have yo-yoed in weight over the years seem to struggle more; those fat cells seem to remember readily how to deposit fat. Even women who have no weight gain during this transition will have a waist circumference increase of up to two inches.

Minimizing the weight gain starts with maintaining a healthy weight over time; those who are most successful in this transition benefit from years of stability at a healthy body weight leading into those years.

Those menopause transition years will be an added challenge, so start to make small healthy changes early on. Women lose muscle mass quite readily at this time of life, so work to maintain or gain muscle with strength training activities.

It’s a fact of life that at this point, it takes more effort to get the same results, requires more dietary caution and exercise, and leaves little room for not paying attention. My motto: You’re now high maintenance; behave like it!

FDA Approves Drug for Sexual Pain

Ladies, we have one more tool in the belt.

Last month, the US Food and Drug Administration (FDA) approved a new drug to treat the vaginal and vulvar pain associated with loss of estrogen in older women.

That pain is called dyspareunia, and it’s caused by the changes in the vagina and genitals that occur when we lose estrogen during menopause. As we’ve said (often), our vaginal tissues become thin, dry, and fragile as our estrogen levels decline, which can make sex very uncomfortable. Dyspareunia is common, and it doesn’t get better on its own.

Until now, treatment options have included using moisturizers (regularly) and lubricants (before sex) or replacing estrogen, either topically in the vagina or through hormone replacement therapy.

Now there’s a pill that you take once a day.

Osphena is called a “selective estrogen receptor modulator,” or SERM. Although it’s not a hormone, it works like one in that it affects some estrogen-sensitive tissues, like the vagina and the uterine lining (the endometrium). The vagina will thicken and become less fragile while other tissues, such as the breast, are affected very little.

In a 12-week trial of almost 2,000 women here in the US, the researchers saw a “statistically significant improvement” in the pain level of the women who took it compared with a control group.

Of course, there’s no free lunch when it comes to pharmaceuticals. Some common and less-serious side effects include hot flashes, vaginal discharge, muscle spasms, and sweating. But a few uncommon and more serious side effects include blood clots, stroke, and vaginal bleeding that can indicate cancer of the endometrium.

That’s why the drug comes with a black box warning from the FDA, and why the FDA advises taking it in the smallest amounts and for the shortest time possible.

It’s also uncertain whether the condition will reverse itself once the drug is stopped.

Despite the scary black box, I’m thinking that Osphena gives us another option. It might not be our first choice for long-term use. It still isn’t the magic bullet for all menopausal ailments.

But it might provide a little short-term boost, for example, to make a woman with severe dyspareunia more comfortable until the moisturizers or the topical estrogen kicks in. And until her renewed sex life helps rejuvenate the vagina because sex, in case you forgot, “is beneficial for maintaining vaginal health,” says Dr. David Portman, lead researcher in the Osphena trials for safety and effectiveness.

Q: What should I know about Estrace?

Estrace is a bio-identical form of estradiol, a plant-based version of the same estrogen made by our ovaries. It comes in two forms—oral (systemic) and vaginal (localized). I use very little oral estrogen in my practice, because we've learned that transdermal estrogen (delivered by patch, gel, or spray or other forms that deliver it through the skin) is safer than oral. Because it's not metabolized by the liver, it doesn't carry the same risk of thrombosis.

Vaginal Estrace is great from a therapeutic perspective—that is, it's very effective for treating vaginal atrophy. Because it's a cream, though, many of my patients don't love it: Some find creams messy to apply. It's important to find a form of localized hormones that each patient will actually use!

Hormone Therapy: The Latest from NAMS

The North American Menopause Society (NAMS) has just published its seventh position statement about hormone therapy in the ten years since the Women’s Health Initiative (WHI) linked a whole bunch of unpleasant side effects, notably breast cancer, to hormone replacement therapy.

Before that groundbreaking study, estrogen was the wonder drug that alleviated menopausal symptoms, such as night sweats and hot flashes, and kept our sexual parts juicy. Once a woman reached “that age,” hormone replacement began.

The WHI study was like yelling “fire” in a crowded theater—everyone ran for the exit. From the fountain of youth, estrogen therapy became the disinherited stepchild, suddenly viewed with anxiety and suspicion.

But with ongoing research over the past decade, the effect of hormones is understood better, and the role of hormone therapy is more refined, nuanced—and safer.

Thus the need for all those updates. “In reviewing the recent scientific publications, NAMS determined that there are enough differences now between the effects of combined estrogen plus progestin (EPT) therapy versus estrogen therapy (ET) alone that it was time to make some changes,” said Dr. Margery Gass, executive director, NAMS, in an interview with The Female Patient.

Plus, as NAMS reasserts, hormone therapy is still the most effective treatment for those pesky, and sometimes debilitating, menopausal symptoms. (Hormone therapy shouldn’t be confused with localized hormones in the form of a cream, tablet, or ring that are used in the vagina to treat dryness and discomfort. These aren’t absorbed into the bloodstream, but they don’t treat other menopausal symptoms, either.)

So here’s the takeaway from the latest NAMS position statement:

  • Hormone therapy for women who have NOT undergone a hysterectomy (who still have a uterus) is usually estrogen plus progestin (EPT) because progestin protects against endometrial cancer. If therapy is started early in menopause and continues for less than 3 to 5 years, the risk of complications from breast cancer is low. The increased risk of side effects found in the WHI study was in older women (above age 60) or after long-term use of hormone therapy.
  • There is no greater risk of heart disease from hormone therapy for healthy women under 60. Risk of blood clots or stroke is a little higher—“less than 1 in every 1000 women per year taking HT,” according to the NAMS position statement. That risk can be further reduced with non-oral or transdermal estrogen therapy.
  • Estrogen alone, which is prescribed for women who have had a hysterectomy, has no increased risk of side effects, even after 7 years of therapy.
  • Hormone therapy comes in several forms—a low-dose pill or by patch, gel, skin spray, or cream. These may have fewer side effects than the regular-dose pill, but more research is needed to determine that.
  • It's important to consider hormone therapy for the right woman, at the right time, and via the right products to maximize benefit and minimize risk. A careful consideration of your own history as well as your family history will help in making that decision.
Because the issue is complex and research is ongoing, NAMS will undoubtedly continue to update its position, but the bottom line, according to Dr. Gass, is that “both these therapies (EPT and ET) are relatively safe for women who are bothered by symptoms of menopause, and who would like to use hormone therapy for a while.”

New VA Treatments in the Pipeline

Sometimes we medical people get to hear about medications and treatments before they hit the doctor’s offices and pharmacies. Recently, MiddlesexMD advisor Dr. Michael Krychman interviewed Dr. James Simon, a well-connected expert in women’s sexual health, about new treatments that are under development to treat vulvovaginal atrophy (VA).

If you recall, VA is the thinning and inflammation of your delicate genital tissues, including the vagina, which is caused by loss of estrogen after menopause. As you can imagine (or already know), it causes genital irritation, an increase in minor infections, and uncomfortable—or downright painful—sex.

VA doesn’t go away, and it doesn’t get better by itself—it requires treatment, usually in the form of estrogen, whether taken internally or applied topically. Topical estrogen creams, tablets, and rings can be very effective in treating the effects of VA.

But a few new approaches are also under investigation. They are:

  • DHEA suppositories. DHEA (which, if you must know, stands for dehydroepiandrosterone), is a steroid that, according to Dr. Simon, is “taken up by the vaginal cells themselves, which convert them to testosterone and estradiol.” The estradiol eases symptoms of VA, and the testosterone improves muscular function and makes the vagina and clitoris more sensitive, so it also gives the libido a little boost. None of it is absorbed into the system, so the medication should be safe for women with breast or ovarian cancers. Don’t expect to see this little number on pharma shelves too soon. Dr. Simon advises patience, since the treatment in still in clinical trials and then must be approved by the FDA.
  • Treatment for VA in pill form. Because many women (and their partners) find topical treatments for VA—creams, rings, suppositories—messy, unpleasant, and a sex inhibitor, a new drug that is readily absorbed by the estrogen receptors in the vagina, but not in other places, such as the endometrium, is being tested.
  • Very low-dose estrogen tablet. In an ongoing effort to find the lowest effective dose of estrogen, Novo Nordisk, the manufacturer of Vagifem, recently found that 10 micrograms is effective in treating symptoms of VA. “It seems to work extremely well, even at these extraordinarily low doses,” said Dr. Simon. And even after taking it for a year, he points out, this dosage amounts to just over 1 gram of estrogen, an amount that is probably safe even for breast cancer patients. The disadvantage, warns Dr. Simon, is that, while the medication treats vaginal symptons well, it might not be as effective for the vulva (the external genitalia). In this case, women may still need an estrogen cream for the very important vulvar care.
Since over 40 percent of post-menopausal women experience symptoms of VA, an effective treatment that doesn’t increase our cancer risks would make us—and our partners—very happy. Take heart. “Many companies are dedicated to innovative treatments without rise in systemic hormones,” said Dr. Krychman.

Q: Is my doctor right to keep me off estrogen?

You say your physician is reluctant to prescribe any hormones because you had a pulmonary embolism 10 years ago. After a hysterectomy, you're coping with physical issues reasonably well, but have vaginal dryness and pain with intercourse.

The clotting risks associated with estrogen use are documented to be with oral administration of the hormone. Oral estrogen is metabolized through the liver, which increases a clotting protein and puts women at greater risks for thrombosis or blood clots. Multiple studies suggest that other methods of administering estrogen—vaginal or transdermal applications—do not carry the same risks. I have many patients on non-oral estrogen who have had thrombosis.

As we get older, we have more risks for clotting: inactivity, weight gain, high blood pressure, and so on. We can't eliminate all the risks, but we don't increase that risk through non-oral extrogen—and your vagina is hungry for estrogen!

I'd call your OB/Gyn's attention to the ESTHER study. The conclusion of that study:

Oral but not transdermal estrogen is associated with an increased VTE [Venous Thrombus Embolism] risk. In addition, our data suggest that norpregnane derivatives may be thrombogenic, whereas micronized progesterone and pregnane derivatives appear safe with respect to thrombotic risk. If confirmed, these findings could benefit women in the management of their menopausal symptoms with respect to the VTE risk associated with oral estrogen and the use of progestogens. [2007;115:840-845]
If your physician is still unwilling to work with you to address this issue, you can look for a certified North American Menopause Society health care provider in your area at their website, menopause.org.

Q: Could fibroids cause tenderness during and after intercourse?

You say you were diagnosed five years ago with fibroids, and you've reached menopause (one year without periods) quite recently. The good news is that fibroids tend to shrink in menopause, so they're unlikely to be causing the soreness you describe after deep intercourse.

The less good news is that your symptoms sound most consistent with vaginal atrophy, the typical consequence of the absence of estrogen in the vagina. I'd recommend that you start using a vaginal moisturizer or vaginal estrogen as soon as possible. The moisturizers are readily available; you'll need a prescription for the estrogen, which comes in a variety of forms for local application.

What you're experiencing is normal and easily treated—more good news!