Elestrin estradiol gel 0.06%

Menopause
and Treatment Options

Frequently Asked Questions About Menopause

What is menopause?

Menopause is a perfectly normal and natural event in a woman's life marking the end of her menstrual cycle. During menopause, a woman's ovaries stop producing eggs, her body produces lower levels of estrogen and other hormones (like progesterone), and menstruation becomes less frequent, eventually stopping altogether.1

When does menopause usually happen?

Most women experience menopause between the ages of 40 and 58, with the average age being 51.1 A woman who has had both ovaries surgically removed may begin menopause earlier.

How will I know if I'm "starting" menopause?

During the transition to menopause—a phase known as perimenopause—you may experience certain symptoms such as irregular menstrual periods, hot flashes, vaginal dryness, trouble sleeping, and mood swings. Perimenopause can last 6 years or more.1 Elestrin is approved by the US Food and Drug Administration (FDA) for treatment of moderate-to-severe hot flashes associated with menopause.

What is a hot flash?

A hot flash (or a hot flush, as your healthcare provider may call it) is a common menopausal symptom caused by the decrease in estrogen level that naturally occurs in a woman's body with aging. A hot flash produces a feeling of heat and redness, primarily on a woman's face and neck. Her skin feels hot and she often sweats. Hot flashes can come on fast, be very intense for a few minutes, then gradually weaken and go away. They can occur anywhere from a few times a day to up to 15 times a day or more. Treatments such as hormone therapy can reduce the frequency and severity of hot flashes.

What are the symptoms of menopause?

The type and severity of menopausal symptoms vary from woman to woman. Common symptoms include: irregular periods; vaginal dryness; hot flashes; trouble sleeping; mood swings; and thinning hair.1 Elestrin is approved by the US Food and Drug Administration (FDA) for use in the reduction of moderate-to-severe hot flashes associated with menopause.

Do all menopausal women experience symptoms?

Not all women going through menopause experience symptoms but many do. The type and severity of symptoms varies from woman to woman.

What is estrogen?

Estrogens are hormones produced by the ovaries that regulate the growth of female reproductive organs. Three main naturally occurring estrogens in women are estradiol, estrone, and estriol. During the years leading up to and including menopause, a woman's body produces less estrogen. Physicians may suggest in appropriate cases that you supplement the amount of estrogen in your body by taking hormone therapy.1

What is estradiol?

Estradiol, also called 17 beta-estradiol, is the primary estrogen produced by women in their reproductive years. Estradiol is available as an ingredient in many types of hormone therapies.1

Can a hysterectomy cause menopause?

Unlike when a woman has both ovaries removed, the removal of a woman's uterus (a procedure known as a hysterectomy) will not automatically cause menopause to start if her ovaries are still in place. A woman who has had a hysterectomy may, however, experience an end to her ovarian estrogen production approximately 2 to 3 years earlier than usual.1

Do I have to go through menopause?

All women go through menopause, but each goes through it in her own unique way.

What can I do to reduce my symptoms?

Many women who want to reduce their hot flashes and night sweats find relief with hormone therapy, such as estrogen therapy. Other women may look to herbal or alternative treatments.

What types of estrogen therapies are available? How can I tell which kind is right for me?

There are 2 major types of estrogen therapy for the treatment of hot flashes—oral estrogen (available in pills) or transdermal (through the skin) therapies (available as either a patch or a topical gel, cream, or spray). There are a number of factors to consider when deciding which option is best suited for you, including your medical history, lifestyle, personal preferences, and the benefits versus risks of each. Be sure to talk to your healthcare provider to determine which treatment option may be best for you.

What should I know about the findings of 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 161,809 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 estrogen therapy alone was associated with an increased risk of heart attacks while estrogen-plus-progesterone was linked with an increase in breast cancer.2,3

Since WHI, new lower-dose and transdermal 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.3-6

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

What should I know about compounded bioidentical hormones?

The term "bioidentical" can be confusing. Bioidenticals are hormone medications that contain hormones that are chemically identical to those produced by the body. Many well-tested, FDA-approved, brand name estrogen products are considered "bioidentical". Often, though, the term bioidentical is used to refer to compounded hormones or mixtures that are created by compounded pharmacies. To read more about these compounded bioidenticals, click here.

Who should not take hormone therapy?

Not everyone is a candidate for hormone therapy. Estrogen products have risks and most importantly, should not be used in women who have a history of breast cancer, certain heart conditions, abnormal vaginal bleeding, or blood clots. Additional important risk information may be found at the bottom of this page. Always talk to your healthcare provider if you have any questions about whether hormone therapy may be right for you.

Are herbs and natural remedies effective in treating hot flashes?

According to most scientific studies, there is no substantial scientific evidence to support that soy-based products or herbs, effectively treat hot flashes. These products are not FDA-approved and some studies have suggested that they do not work any better than placebo (substance containing no medicine).7

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. North American Menopause Society. Menopause Guidebook: Helping Women Make Informed Healthcare Decisions Around Menopause and Beyond, 6th ed. Available at: http://www.menopause.org/edumaterials/guidebook/guidebook.aspx. Accessed July 16, 2010.
  2. 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.
  3. 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.
  4. US Food and Drug Administration Web site. Available at: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Accessed July 20, 2010.
  5. 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.
  6. North American Menopause Society updates guidelines on postmenopausal hormone therapy. Available at: http://cme.medscape.com/viewarticle/576970. Accessed July 20, 2010.
  7. Newton KM, Reed, SD, LaCroix AZ, Grothaus LC, Erlich K, Guiltinan J. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo. Ann Intern Med. 2006;145(12):869-879.