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A study of Elestrin demonstrated that it provides significant reductions in both the frequency and severity of moderate-to-severe hot flashes and night sweats.

The women in the Elestrin study were experiencing an average of 13 hot flashes per day when they entered the study.1,2 The average severity score for the women in the study at the beginning was 2.4 on a 4-point scale, where 3 = Severe.1,2

Important Safety Information and Black Box Warning

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

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia. 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 endometrial cancer. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

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Elestrin significantly reduced the number of hot flashes.

The average number of hot flashes among the group had been significantly reduced by week 3 using the 2-pump dose, and by week 5 using the 1-pump dose.1

Elestrin significantly reduced the severity of hot flashes.

The severity of hot flashes was also significantly reduced by Week 4 using the 2-pump dose, and by Week 5 using the 1-pump dose.1,2

It’s simple for your doctor to adjust your dose depending on how severe your symptoms are.

Elestrin delivers a metered dose—the same amount with each pump.

If your hot flashes are more severe, your doctor may start you on the two-pump dose to help get your symptoms under control. Your doctor may then adjust your dose, depending on how your respond to Elestrin therapy.

References:

1.    Simon JA, Bouchard C, Waldbaum A, et al. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007;109:588-596.

2.    Elestrin™ [package insert]. San Antonio TX: Kenwood Therapeutics, 2007.

 
   

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.

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A Survey of 300 untreated menopausal women reveal what they want from the application of transdermal estrogen therapy†:

"I want a product I can apply and forget it."

"I’d rather just rub the product in and forget it’s there."

"For me, it’s easier to get into a daily habit."

"I like the control of applying [it] right on my upper arm."

"Make it clear and easy to apply."

†A blinded survey of 300 women with hot flashes to evaluate the importance of various attributes of transdermal estrogen therapy and the preference for various topical estrogen therapy products. Azur Pharma; 2009.