New Transdermal Options in Managing Menopause Allow for Better Individualization of Therapy

Menopausal women have an increasing number of treatment options available to them, including transdermal estrogen therapies with different delivery systems. These options are welcome because they allow women more choices in tailoring hormone therapy to their individual needs and preferences. Individualizing care is the key to effective treatment.

The Transdermal Trend

Over the past decade, transdermal estrogen delivery products have become increasingly popular because they allow estrogen to be absorbed directly through the skin into the bloodstream without first passing through the liver. This helps minimize the side effects associated with estrogen pills, such as the risk of cardiovascular complications. When taken orally, estrogen must be first filtered through the liver where it is modified before entering the bloodstream, increasing the risk of blood clots and elevated levels of a cardiovascular risk factor called C-reactive protein. By avoiding this initial processing by the liver, transdermal therapies decrease the risk of cardiovascular side effects and, with their direct absorption into the bloodstream, effectively manage menopausal symptoms with a lower dose of estrogen than oral therapies.

Transdermal delivery systems also provide more consistent management of vasomotor symptoms, such as hot flashes and night sweats that result from fluctuating levels of estrogen. Whereas the delivery of oral estrogen peaks and then declines, transdermal delivery systems allow a continuous absorption of estrogen through the skin at a steady level without fluctuations. This consistent delivery of estrogen provides the stable hormone levels needed to better manage menopause symptoms throughout the day.

The patch, which became available about a decade ago, was the first FDA-approved transdermal estrogen delivery system. More recently, newer options such as lotions and gels have allowed healthcare providers to further individualize therapy for their patients, specifically tailoring therapy to a woman's symptoms, medical history and delivery preference.

The newest hormone therapy (HT) option approved by the FDA, a transdermal gel called EstroGel (estradiol gel), demonstrates how we have moved beyond oral hormone therapy to provide a delivery system that can work particularly well for women. Applied once daily to one arm from shoulder to wrist, the gel is absorbed directly into the bloodstream. EstroGel does not need to be massaged or rubbed-in and dries in as little as two to five minutes. The transdermal delivery of EstroGel provides a consistent and continuous supply of estradiol, an estrogen that is bio-identical to the estrogen produced by the ovaries prior to menopause. The new gel allows estrogen to be absorbed through the skin, minimizes skin irritation often associated with the patch and avoids the adhesion problems that sometimes cause the patch to come off. Once applied, the gel also is a visually discrete therapy, which may be important to physically active women.

The only FDA-approved estrogen therapy available as a gel, EstroGel has been a prescribed therapy for more than 25 years in Europe. As with any estrogen preparation, it should be used with a progestogen in women with an intact uterus. In a clinical study, researchers found that postmenopausal women, who had been experiencing moderate-to-severe hot flashes at least seven times a day or 60 times a week, had significantly fewer hot flashes after receiving EstroGel, when compared to those receiving a placebo; women using the gel also had an overall reduction in the severity of hot flashes. Since vasomotor complaints are the primary reason women begin estrogen therapy, this new option may appeal to women who experience side effects when taking oral estrogen, have skin irritation when using the patch, or are looking for new options for estrogen delivery.

The Value of Hormone Therapy

As women age, timely and appropriate estrogen replacement is needed because estrogen not only impacts the reproductive system and the genitalia, but also the brain, bone, heart, blood vessels, skin, and the ability to see and hear. Without estrogen, it appears that many women may be at higher risk for certain diseases. On average, women in the United States now live 30 to 40 years beyond the time when the ovaries stop producing estrogen. Once estrogen production ends, most women experience the vasomotor symptoms of menopause, such as hot flashes, night sweats, palpitations, headaches, mood swings, and anxiety reactions. By replacing the essential estrogen hormone, hormone therapy (HT) helps women avoid these disruptive, disorienting and sometimes debilitating symptoms. As with any medication, women should discuss the side effects of estrogen with her healthcare provider.

How Should Hormone Therapy be Prescribed?

Individualized therapy is the key to effective HT treatment. Therapy that is customized to the needs of the individual woman will help minimize side effects and maximize the effectiveness of treatment. Women should select a healthcare provider who specializes in menopause treatment, can devote time to discuss her particular symptoms, and tailor treatment to manage those symptoms. Healthcare providers and patients should plan an appropriate therapy based on medical and family history, lifestyle, dietary and exercise habits, body shape and symptoms. Additionally, the patient must communicate her treatment expectations to the healthcare provider: Is she seeking short-term benefits (relief of vasomotor systems such as hot flashes) or a long-term benefit (maintenance of health and vitality as she ages)? HT should be assessed annually; patient and healthcare provider should discuss how well the current treatment is working, how the patient's body may have changed over the year, and whether newly available options should be considered as treatment. While estrogen is the most commonly prescribed hormone for menopausal women, there may be a need to add androgen to the treatment for women whose symptoms have not responded to estrogen therapy. Women who have had a hysterectomy may take estrogen alone, but, because estrogen causes cells to multiply and may increase the risk of uterine cancer, women with an intact uterus may need progesterone as well.

Who Should Receive Hormone Therapy?

HT is the most effective FDA-approved treatment for the relief of moderate to severe menopausal symptoms. It is an effective, safe and reliable treatment option, especially if customized to a patient's needs. Many studies have shown that HT options using appropriate estrogen, progesterone and other hormone combinations can safely and effectively help manage menopausal symptoms. These treatments are also used to effectively treat vaginal dryness and as a way to prevent osteoporosis.

While initial reaction to the Women's Health Initiative (WHI) study in 2002 caused many women to stop HT, healthcare providers and patients have come to realize that WHI did not provide any evidence to dispute the fact that HT is the best way to treat a typical woman in her forties or fifties seeking relief for moderate to severe menopausal symptoms. Lost in the media coverage of the study were the essential facts that WHI studied women whose average age was 64 and who, on average, were 12 years beyond menopause before starting hormone therapy. Thus, the study told us little about the needs of women who begin individualized hormone therapy immediately after menopause.

Women are "Naturally" Responsive to Bioidentical Treatments
In the confusion that followed the release of the initial Women's Health Initiative (WHI) study results, many women turned to alternative, so-called "natural" treatment options such as black cohosh, dong quai and evening primrose oil. It is important for women to understand that, although these products may be natural to the plant world, they are not natural to a woman's body, and they have not been approved by the FDA as safe and effective treatments.

The therapeutic reality is that a woman's body is much more responsive to estradiol and the micronized progesterone, which are bio-identical to the estrogen and progesterone produced by the ovaries. Women respond to these prescription products because they are so similar to what a woman's body makes naturally prior to the midlife changes in her body. Estradiol is available through a prescription in many FDA-approved estrogen products, including EstroGel, and micronized progesterone is available in a capsule, Prometrium.

As a further caveat, some of the over-the-counter herbal products have been reported to be associated with serious side effects. One reason for this is that the use of OTC herbal products is often potluck therapy. With no systematic government oversight in place, what is on the product label may not be in the jar, and what is in the jar may not be on the label. Additionally, these products have not undergone the appropriate clinical trial for safety and efficacy required by FDA-approved medications. In the few studies that have been completed, many have been shown not to work beyond an initial placebo effect.

Caution is also advised for women considering natural hormones compounded by a pharmacy. These new remedies of natural progesterone and natural estrogen are being touted as bio-identical, customized formulations based on each woman's hormone levels. Again, these are not FDA-approved preparations, and there are no guidelines for their use.

In a separate category of treatment, some antidepressants have been found to relieve hot flashes and mood swings in some women. However, these medications may have side effects in some patients, including drowsiness, dry mouth, nausea and loss of both sexual desire and sexual response.

Conclusion

HT options using appropriate estrogen, progesterone and other hormone combinations can safely and effectively help manage menopausal symptoms. Transdermal hormone therapies provide some distinctive advantages over oral estrogen. When patient and healthcare provider discuss how to individualize care, they should determine which treatment approach best suits the patient's health needs and lifestyle preferences. Therapy that is customized to the needs of the individual woman will maximize the effectiveness of treatment.

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Created: 11/23/2004  -  Donnica Moore, M.D.