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Delivery & Safety

A novel, effective delivery system

Once-daily emulsion in a topically applied lotion

  • Lotion from two premeasured foil pouches applied to the legs
    delivers 0.05 mg of 17ß-estradiol directly to the systemic circulation
  • Soy-based lotion leaves skin feeling soft, smooth, and moisturized
  • Unscented and preservative-free

Demonstrated safety & tolerability

Topical delivery...

  • Avoids first-pass metabolism by the liver

Lotion formulation...

  • Contains no preservatives or adhesive residue
  • Low incidence of application-site reactions

In a clinical trial...

  • No serious treatment-related adverse events (AEs)
  • No clinically relevant differences in AEs
    (ESTRASORB vs placebo)
  • The most frequently reported adverse events were infection, sinusitis, pruritis, breast pain, and endometrial disorder





The most frequently reported adverse events (≥5% and more frequently than placebo) in clinical trials for ESTRASORB were: Infection; Sinusitis; Pruritus; Breast pain; and Endometrial disorder.
ESTRASORB should not be used in close proximity to sunscreen application because estradiol absorption may be increased. (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption.)
Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical rather than by serum hormone levels (eg, estradiol, FSH).

Simon JA; for The ESTRASORB Study Group. Estradiol in micellar nanoparticles: the efficacy and safety of a novel transdermal drug delivery technology in the management of moderate to severe vasomotor systems. Menopause. 2006;13:222-231.
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ESTRASORB is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Estrasorb should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep-vein thrombosis, pulmonary embolism or history of these conditions; active or recent (eg, within the past year) arterial thromboembolic disease (eg, stroke, myocardial infarction); liver dysfunction or disease. ESTRASORB should not be used in patients with known hypersensitivity to its ingredients; known or suspected pregnancy. There is no indication for ESTRASORB in pregnancy. There appears to be little or no increased risk of birth defects in women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy (see PRECAUTIONS in full Prescribing Information).

Estrogens increase the risk of endometrial cancer. Close clinical surveillance of all women taking estrogen 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 estrogenic doses. (see WARNINGS, Malignant neoplasms, Endometrial cancer).
Cardiovascular and other risks. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (see WARNINGS, Cardiovascular disorders and Dementia).
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies, Warnings, Cardiovascular disorders and Malignant neoplasms, Breast cancer).
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo.

It is unknown whether or not this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies, Warnings, Dementia and PRECAUTIONS, Geriatric Use). Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations of estrogens and progestins were not studied in the WHI 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.