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Posts Tagged ‘hormone therapy’

We’ve been following the development of Flibanserin, also called “pink Viagra,” since 2010, when its developer shelved it after hitting a bump in the road to FDA approval. Several years later, we were talking about alternatives, Librido and Lybridos, which were moving forward with clinical trials (and have not yet been approved).

We’ve just learned that the manufacturer that now owns Flibanserin has filed an appeal of the FDA denial, saying that other drugs have been approved with less data and more extreme side effects. And that’s reignited discussion about whether pharmaceutical products targeting women’s sexual disorders are evaluated on a level—or relevant—playing field.

Flibanserin, Librido, and Lybridos (and a small handful of others) are all drugs designed to play a part in awakening libido for women. They counter hypoactive sexual desire disorder (HSDD), in physicians’ terminology (the rest of us call it “not tonight—or tomorrow night, either” syndrome). There are, for context, a couple of dozen FDA-approved drugs for the comparable problem among men, including Viagra.

I don’t have the insider information I’d need to assert a double standard, although people I know and respect—like my colleague Sheryl Kingsberg—suggest there is one. Women’s health psychologist at University Hospitals MacDonald Women’s Hospital, Sheryl said, “There’s a double standard of approving drugs with a high risk for men versus a minimal risk for women.” The side effects for Flibanserin, for example, were reported as dizziness and nausea; Sheryl compares those to side effects of penile pain, penile hematoma, and penile fracture—all from a drug that was approved.

That does sound like some extra protectiveness of women. Given my focus on sexual health for women, I run into a lot of cultural expectations and hesitations; we Americans are still just a bit prudish when it comes to, especially, older women having sex. That’s in spite of what I see in my practice every day: Women themselves want to live whole lives, which means being physically active, emotionally engaged, and sexually active within their relationships.

I recognize that sexuality for women is complex, and there won’t be a “magic bullet.” For women, arousal and desire is a mix of emotional intimacy, biological responses, and psychological responses; a drug won’t address all of the components. But because I’m often working with patients to untangle interlocking causes of problems with sex, I’m eager for as many tools as possible, including pharmaceuticals.

As a physician, I also see the need to evaluate trade-offs and risks. I’ve talked before about the pros and cons of hormone therapy. For some women, living longer doesn’t really count if they’re not able to be active—including being actively sexual. “Pink Viagra” drugs may well require the same kind of close collaboration between women and their doctors to evaluate risks and benefits. Again, Sheryl: “Give women a chance to decide for themselves, within reason. There is no drug out there that has no risk.” In the case of Flibanserin, only 8 percent of testers said the side effects were bad enough to make them want to drop the drug.

These decisions by the FDA are also important because pharmaceutical research is done by businesses, businesses that can decide that one problem or another is too expensive or too complicated to take on. Sheryl sees this, too, saying, “My worry is that research in this area will dry up and will leave many women without a pharmacological option.”

One way to make your voice heard about the importance of continued research is by signing the International Society for the Study of Women’s Sexual Health (ISSWSH) WISH petition. Our sexual health is integral to our overall health, and we need more investigation and even-handed, common-sense consideration of therapies for women.

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You’re wondering whether your hormone therapy, designed to address your hot flashes, is having an unintended negative effect on your libido. The good news is that adding estrogen is better for sex, in general terms. So you don’t have to take back your hot flashes to get your libido back!

The less good news is that libido is sometimes a puzzle to solve. I’ve found that non-oral estrogen addresses hot flashes with fewer unintended effects on sexual desire. The reason is that oral estrogen enters our systems in ways that affect metabolization in the liver and resulting circulating testosterone levels. And testosterone, though not entirely understood, is as important to women’s sexuality as it is to men’s!

You might start by changing to non-oral or transdermal estrogen; it will likely take up to 12 weeks to see whether there’s an effect. And if that doesn’t make enough difference, there are other options you can explore with your health care provider.

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Recently, I was browsing through an online discussion board about the pros and cons of hormone replacement therapy. I ran across this comment from a participant: “I’m going to try bioidentical hormones like Suzanne Somers. I’ve heard they’re safer.”

Whoa! I thought. Let’s do some objective homework first, and weigh the risks before you jump in.

Celebrity endorsements notwithstanding, bioidentical hormone replacement therapy (bHRT) is neither the miracle cure nor fountain of youth touted by Ms. Somers. Nor is it some kind of snake oil concocted by salacious quacks or unscrupulous doctors and pharmacists.

The truth is, of course, much more nuanced.

As a physician, I’d always opt for more treatment choices when it comes to helping women with the unpleasantries of menopause. I want more drugs in the arsenal, more ways to treat hot flashes, sleeplessness, and loss of libido. However, the entire topic of bioidentical hormones is so laden with emotion and misinformation that it takes a very fine point to tease fact from hyperbole.

We laid the groundwork on bioidenticals before, but the issue continues to befuddle and mislead, so let’s circle back and fill in some gaps.

Any hormone therapy, whether bioidentical or synthetic, is only intended to ease menopausal symptoms. Hormones were never meant to keep your memory sharp or your hair shiny or your skin taut. Hormones are not a fountain of youth. The latest medical guidelines state that hormones should be taken at the lowest possible dose for the shortest period of time needed to ease symptoms. This is because hormones, whether bioidentical or synthetic, are drugs and they interact with other systems in the body, sometimes in ways that are not well understood.

Point #1. Menopause isn’t a disease; it’s a natural transition. Hormone therapy is intended neither to keep your hormones “in harmony” nor to keep menopause at bay indefinitely. Hormone therapy is intended to ease the symptoms of the menopausal transition when they are interfering with your life.

Next, bioidenticals aren’t necessarily “natural” and therefore “safer.” The marketing message that hooks women is that bioidentical hormones are derived from “natural” sources and are therefore safer than hormones from other sources.

Bioidenticals are estrogens that are indeed made from plant sources, but they are processed (synthesized, if you will) to create a hormone that can be absorbed by humans. “All plant-derived hormone preparations, whether they come from a compounding pharmacy or a large commercial pharmacy, require a chemical process to synthesize the final product,” writes Dr. Oz in this article.

With bioidenticals, however, you end up with a molecule that is exactly like (identical to) human hormones, whereas non-bioidentical hormones are similar but not identical.

Any hormone, whether those your body produces or those you ingest, affects your body. Also, the delivery method, whether a patch, pill, or vaginal cream, also affects the way your body absorbs and responds to the hormone.

Point #2: Don’t equate “bio” with something “natural” and therefore risk free. Taking any hormone involves some risk. (Decisions about hormone therapy need to be based on careful consideration for each individual—understanding both the potential risks and benefits for that woman.) Bioidentical hormones are so-called because the molecule is identical to the human hormone and because they are derived from plant sources, even though they must be synthesized to be useful.

“So ‘natural’ doesn’t necessarily equal ‘safe’—and may simply be a euphemism for ‘unregulated,’” according to this article in the Harvard Women’s Health Watch.

You can, we should note, get bioidentical hormones that are FDA approved and regulated. Many familiar brands of hormonal rings, creams, patches, pills, and gels are both commercially manufactured by pharmaceutical companies and bioidentical. These include Estrace, Femring, Vivelle, Vagifem, and Prometrium, and more.

You know what you’re getting with these products. You know that the active ingredient is in the form and dosage that the label says it is. That kind of uniformity and “safety” is the assurance provided by FDA testing and approval.

Point #3: Many major brands of commercially manufactured hormones are both bioidentical and FDA approved.

Next, let’s understand what “custom-compounding” means. Many bioidenticals are touted as natural, safe, and custom-made just for you to bring your hormones back in balance. Custom-compounded drugs are made in small, customized batches by pharmacies that specialize in custom-compounding. They can be prescribed by a clinician.

Custom-compounding is very helpful when a patient needs a special dosage of a medication, or a different delivery method, or is allergic to a filler in a commercial drug. Maybe, for example, you need a lower dose of progesterone than is commercially available, or you need it in a vaginal cream, and the big pharmas only make it for administering orally.

However, neither the process nor the product is FDA-regulated or approved, and in fact, studies have shown that they are much less consistent than commercial products. In a few highly publicized cases, contaminated medications distributed by custom-compounders have been responsible for serious illness, infection, and death. An example is the outbreak of fungal meningitis in the fall of 2012.

The problem with custom-compounded hormones arises with claims of customized products that are safe, natural, and that will restore hormonal balance, among other things.

In actuality, it’s not possible to accurately pinpoint hormonal levels in an individual because they are constantly changing. The hypothalamus, pituitary and ovaries (the HPO axis, as we call it) work in a very integrated and precise way to direct hormone production. Our replacements aren’t able to replicate that concert of events, but we can do a good job of replacing the hormones more consistently, which many women prefer to the ‘ups and downs’ we’re familiar with. The only way to determine an effective dose is through symptom control—the lowest dose that relieves a woman’s symptoms. “Salivary and blood testing of hormone levels used by custom compounders is meaningless for midlife women as their hormone levels vary throughout the day, and from day to day” is the North American Menopause Society position.

“This doesn’t mean that you shouldn’t consider compounded hormones. Just realize that, in a real sense, you’re going to be an experiment of one,” says the Harvard Medical Watch article.

Also realize that custom-compounded drugs usually aren’t covered by insurance, and the regimen of testing and compounding gets expensive very quickly.

Point #4. Custom-compounding of drugs is a time-honored practice of making drugs in small batches or according to specific needs (while the processes and products aren’t subject to federal regulation or oversight). Claims that these products are healthier, safer, or somehow contain properties lacking in commercial products should be viewed with suspicion.

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I assume that your hormone therapy is oral or transdermal and systemic. There isn’t evidence that says hormone therapy contributes to weight gain. In fact, some of the research suggests that it can be helpful in maintaining a healthy weight.

Based on my experience, I believe hormone therapy is weight neutral—although if it makes you feel better and sleep better, it can be very helpful to an overall healthy lifestyle, which includes exercise and a good diet.

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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.

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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.

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A definition first: The endometrium is the mucous membrane that lines the uterus. For women who have had hysterectomies, the endometrium is not an issue in planning hormone therapy (HT).

For others, the endometrium is a “target tissue” (like many others) for estrogen and progesterone. During our reproductive years, those hormones signaled the lining of the uterus to thicken (proliferative endometrium influenced by estrogen) and then to shed (secretory endometrium influenced by progesterone), over and over in our menstrual cycle.

Endometrial cancer is a well-recognized consequence of “unopposed estrogen,” a continual message to proliferate and thicken without the proper “opposing” influence of progesterone. Nearly all endometrial cancers will be “estrogen influenced.”

When we plan HT for a woman in menopause with a uterus, we must balance estrogen and progesterone. (And, in fact, for a woman in reproductive years who doesn’t ovulate, which typically triggers progesterone, we’ll compensate with progesterone therapy.)

As with most cancers, there are factors we can’t always explain. Obesity, however, is the most common risk factor; in fact, obese women are at higher risk than their friends on HT including both estrogen and progesterone. Fat (adipose) tissue produces estrone, an estrogen that is very weak but does influence the endometrium. Sometimes we biopsy obese women and find “precancer” of the endometrium; part of our treatment is progesterone in an effort to reduce their cancer risk.

Just one more reason, I’m afraid, to make healthy habits a priority—and to work with your health care provider for HT that takes your health history and priorities into account.

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