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Drug Profile

Low-dose estradiol gel 0.1% for the treatment of vasomotor symptoms associated with menopause

Pages 155-162 | Published online: 10 Jan 2014
 

Abstract

Estrogen therapy (ET) is the most effective treatment currently available for the relief of vasomotor symptoms such as hot flushes and night sweats, which are associated with menopause. Safety concerns associated with long-term use of standard doses of oral estrogens have led to treatment guidelines recommending the use of ET at the lowest effective dose for the shortest duration possible when indicated for treatment of menopausal symptoms. Estradiol gel 0.1% (Divigel®) is a low-dose, ‘patchless’ transdermal formulation of a bioidentical estrogen (structurally indistinguishable from the endogenous human hormone) that has been demonstrated to be effective and well tolerated in the treatment of moderate-to-severe hot flushes. Available at doses of 0.25, 0.5 and 1.0 g (containing estradiol 0.25, 0.5 and 1.0 mg, respectively), estradiol gel 0.1% is applied topically to the skin once daily. At these doses, estradiol gel 0.1% delivers estradiol 0.003–0.027 mg/day at steady-state, the lowest systemic levels of estrogen of any US FDA-approved treatment for vasomotor symptoms associated with menopause.

Financial & competing interests disclosure

Dr Hedrick is a member of the advisory board and has served as a consultant to Upsher-Smith Laboratories, Inc., and as a principal investigator for research involving Divigel. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript, apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. Assistance was provided by Regina Switzer and Mary Prescott with the support of Upsher-Smith Laboratories, Inc.

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