Treatment
Options

Treatment Options for Your Patients

Optimal Treatment Strategy for Vasomotor Symptom Control

Women with low estrogen levels may experience numerous symptoms that vary in severity and duration before, during, and after menopause. As women transition through menopause, vasomotor changes may be some of the most prevalent symptoms experienced.1

When devising a treatment strategy for your patients, it's important to keep in mind the use of estrogen, alone or in combination with a progestin, at the lowest effective dose and for the shortest duration.2 There are many options for your patients including FDA-approved therapy (based on randomized, placebo-controlled trials), compounded hormones and herbal treatments. And, there is considerable difference in the rigor with which these options have been studied for efficacy and safety. With so many options, there is room for confusion.

Educate your patients on the facts about hormone therapy. Dispel the myths. Empower them to continue the treatment dialogue with you. This will provide your patients with the clarity and confidence they need to embrace a smart treatment approach.

Treatment Options and Considerations

In this section you can review some treatment options including:

Hormone Therapy

There are many FDA-approved hormone therapy options for your patients, including oral, transdermal (via patch, gel, cream or spray) and vaginal treatments. Evaluate hormone therapy options.

Compounded Hormones

It is unknown whether compounded hormones, which are not FDA-approved, are properly absorbed or provide the appropriate level of hormones needed in the body.3

Herbal Treatments

Herbal treatments are not FDA-approved. Few of these approaches have been scientifically evaluated in a rigorous clinical setting.4

This table provides an overview of the available treatment options for hot flushes, and serves as a valuable tool for discussion with your patients.

aMixed by a pharmacist according to a healthcare provider's prescription

bBioidentical hormones are hormones that are identical/similar in structure to the hormones women make in their bodies

cRequired for US Food and Drug Administration (FDA) approval

dRequired by the FDA to report adverse events

eDenotes there are such products in that category that fit criteria. Not all products in category meet criteria

Elestrin (estradiol gel 0.06%) contains 17ß-estradiol, the same hormone produced in the female body.2

The novel ATD™ technology of Elestrin provides enhanced permeability which results in a favorable pharmacokinetic (PK) profile.5 In a clinical trial, Elestrin significantly reduced the frequency of hot flushes as early as week 3 with the 2-pump (1.7 g/day) dose.6 The 1-pump (0.87 g/day) dose significantly reduced the frequency of hot flushes as early as week 5.6

Consider Elestrin for your patients with moderate-to-severe vasomotor symptoms associated with menopause. Elestrin is concentrated on a woman's needs and provides significant relief at a low exposure to estradiol.2

Elestrin Patient Education Brochure

You and your patients have options when it comes to estrogen therapy. Naturally, you take into consideration many things when devising an effective treatment strategy for patients.

This Patient Education Brochure is a useful resource for your patients as they consider the treatment options.

Help Your Patients Save With Elestrin

You can help your patients save with Elestrin. Your patients will pay no more than $25 with each Elestrin prescription.

Download and Print the Elestrin Coupon for Your Patients

Indication

Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia. The use of estrogens and progestins has shown an increased risk of breast cancer, myocardial infarction, and pulmonary embolism. The use of estrogen, with or without progestins, has shown an increased risk of stroke, dementia, and DVT while estrogen alone therapy increases the risk of endometrial cancer. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo.

The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of conjugated equine estrogens with medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, 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. Carroll N. A review of transdermal nonpatch estrogen therapy for the management of menopausal symptoms. J Womens Health. 2010;19(1):47-55.
  2. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  3. US Food and Drug Administration. Bio-Identicals: sorting myths from facts. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm. Accessed July 20, 2010.
  4. Newton KM, Reed SD, LaCroix AZ, et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo. Ann Intern Med. 2006;145:869-879.
  5. Alberti I, Grenier A, Kraus H, Carrara DN. Pharmaceutical development and clinical effectiveness of a novel gel technology for transdermal drug delivery. Expert Opin Drug Deliv. 2005;2(5):935-950.
  6. Simon JA, Bouchard C, Waldbaum A, et al. Low dose of transdermal estradiol gel for the treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007;109:588-596.