Elestrin estradiol gel 0.06%

Menopause
and Treatment Options

Understanding Hormone Therapy

Know the Facts. Get the Answers You Need.

Hormone therapy. These words may leave you feeling curious, anxious, or confused. There's been a lot of talk in recent years about the safety and risks associated with hormone replacement therapy providing hot flash & night sweat relief. Some of the information may seem contradictory or confusing. What should you believe? Let's learn more about this important topic.

First, hormone therapy is a type of treatment containing one or more female hormones, most commonly estrogen alone or estrogen/progestin (progestin is a synthetic form of the hormone progesterone and is used only if a women has not undergone a hysterectomy). Estrogen therapy is hormone therapy containing estrogen alone. Because symptoms of menopause are caused by a decrease in the amount of estrogen your ovaries produce, adding estrogen back to your body may be recommended to provide relief of hot flashes and night sweats.

What Should I Know About the Women's Health Initiative?

In 2002, results of the large clinical trial known as the Women's Health Initiative (WHI) were published. This nationwide trial studied nearly 162,000 menopausal women to look at the role of hormone therapy in presumably protecting the heart.

The average age of women in WHI was 63. Women in one arm of the study received a combination of estrogen plus progesterone in pill form. Women in another arm of the study received estrogen alone in pill form. In both cases, the estrogen given was conjugated equine estrogen, meaning that it was a mix of several different estrogens produced from the urine of a pregnant mare. The study found that oral estrogen therapy alone was associated with an increased risk of heart attacks while estrogen-plus-progesterone was linked with an increase in breast cancer.1,2

Since WHI, new lower-dose and transdermal (absorbed through the skin) forms of estrogen have come on the market. The active ingredient in many of the transdermals is estradiol, which was originally harvested from a plant and has the same chemical structure to the 17 beta-estradiol made by the female ovaries. In the absence of comparable data, the risks of these types of products should be assumed to be similar to oral forms.

Today, associations such as the US Food and Drug Administration (FDA), North American Menopause Society (NAMS), and American College of Obstetrics and Gynecologists (ACOG) advise that hormone therapy should be given at the lowest dose that helps, for the shortest time needed.3-5

Be sure to talk with your healthcare provider about whether estrogen therapy may be right for you.

Types of Estrogen Therapy

There are many forms of estrogen therapy available, including pills, patches, gels, and products that can be applied vaginally. Here are the most common formulations of estrogen treatment:

Oral Estrogen (Pills)

There are estrogen products in pill form made for the treatment of hot flashes. Oral estrogens are usually taken daily. Estrogen in pill form first has to be metabolized (changed) in the liver before entering the bloodstream, which is why pills often contain higher amounts of estrogen in order to achieve therapeutic levels of estrogen in the bloodstream.6,7,8 Some pills are made of conjugated estrogens, meaning that they are a mixture of several different estrogens produced from the urine of a pregnant mare. Some pills were originally harvested from plants and made with 17 beta-estradiol, which is identical to the natural hormone produced in your body.

Transdermal Therapies

With transdermal therapies, estrogen is absorbed directly through the skin into the bloodstream. Transdermals do not need to pass through the liver before entering the bloodstream and most of the estrogen applied to the skin enters the bloodstream after passing through the skin. Transdermals are often available using relatively low amounts of estrogen. The impact, if any, of the varying amounts of estrogen entering the bloodstream in pills versus transdermals is not completely understood.6,7,8 The active ingredient in most transdermal hormone therapies is 17 beta-estradiol, which is identical to the natural hormone produced in your body.

There are 2 different types of transdermal therapies:

Estrogen Patches

Estrogen patches, applied once or twice a week, adhere to your skin so that your body can absorb the estrogen they contain. You must make sure that your estrogen patch does not fall off, which can cause you to receive an inconsistent dose of estrogen. Residue from the adhesive on the patch may also irritate your skin.

Topical Estrogens

Topical estrogens, which are a more recent development in transdermal therapies, come in the form of a gel, cream, or spray that is applied directly to the skin. Topicals are invisible once absorbed. They may irritate the skin in addition to causing other adverse reactions.

What About Bioidenticals?

You may have heard about a type of hormone therapy formulation called "natural" or bioidentical hormones. This term is confusing at times and is sometimes used to refer to hormones that are compounded (or custom-mixed) by pharmacists. There are a number of misleading claims associated with compounded bioidenticals. To get the straight story, click here.

All estrogen therapy has risks. Please see important safety information at the bottom of this page.

Indication

Elestrin is indicated for the treatment of moderate-to-severe hot flashes and night sweats associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia (decline in memory or thinking skills). Estrogen and progestin therapy has shown an increased risk of breast cancer, heart attack, and blood clots. Estrogen therapy, with or without progestins, increases the risk of stroke and dementia. Estrogen therapy alone increases the risk of cancer of the uterus (womb).

Elestrin should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past; currently have or have had blood clots; currently have or have had liver problems; or think you may be or know that you are pregnant.

The most frequently reported adverse events in clinical trials were nose and throat irritation, breast tenderness, upper respiratory tract infection, and irregular menstrual bleeding.

You and your healthcare provider should discuss whether Elestrin is right for you or whether you still need treatment with Elestrin.

Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

References

  1. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG committee opinion no. 420, November 2008: hormone therapy and heart disease. Obstet Gynecol. 2008;112(5):1189-1192.
  2. North American Menopause Society. Estrogen and progestogen use in postmenopausal women: 2010 position statement of the North American Menopause Society. J North Am Menopause Soc. 2010:17(2):242-255.
  3. US Food and Drug Administration Web site. Available at: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Accessed July 20, 2010.
  4. American College of Obstetrics and Gynecology Web site. Available at: http://www.acog.org/from_home/publications/press_releases/nr10-01-04.cfm. Accessed July 20, 2010.
  5. North American Menopause Society updates guidelines on postmenopausal hormone therapy. Available at: http://cme.medscape.com/viewarticle/576970. Accessed July 20, 2010.
  6. Carroll N. A review of transdermal non-patch estrogen therapy for the management of menopausal symptoms. J Womens Health. 2010;19(1):47-55.
  7. Hirvonen E, Cacciatore B, Wahlstrom T, et al. Effects of transdermal oestrogen therapy in postmenopausal women: a comparative study of an oestradiol gel and an oestradiol delivering patch. British Journal of Obstetrics and Gynaecology 1997. 104 (suppl16):26-31.
  8. Cheang A, Sitruk-Ware R, Utian W. A Risk-benefit appraisal of transdermal estradiol therapy. Drug Safety 1993. 9 (5):365-379.