Spray-on estrogen relieves hot flushes
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A form of estrogen, estradiol, sprayed on the skin is a safe, effective, and convenient way for post-menopausal women to relieve hot flushes, a study shows.
Evamist, which is marketed by Ther-Rx Corporation, is the first transdermal estradiol spray to be approved by the US Food and Drug Administration for treating moderate-to-severe menopausal symptoms in healthy women, according to the report in the medical journal Obstetrics & Gynecology.
“This estradiol ‘spray-on-patch’ is a treatment option for women who will benefit from the advantages of transdermal estradiol delivery but are intolerant of or are not inclined to use patches, gels, or emulsions,” write Dr. John E. Buster, from Brown University in Providence, Rhode Island, and colleagues.
The spray solution contains estradiol in ethanol, plus a skin-penetrating agent, and is delivered in a precisely metered dose. It is formulated to be retained beneath the skin’s surface where is slowly released over 24-hours. The spray is applied to the inside of surface of the forearm and dries clear in 1 minute; it can’t be rubbed or washed off and it won’t transfer to other people.
In the study, 454 women with eight or more moderate-to-severe hot flushes per day were randomly assigned to receive one, two, or three sprays of estradiol or an inactive placebo daily.
Compared with the placebo groups, all three estradiol groups showed significant reductions in the frequency and severity of hot flushes.
At 12 weeks, patients in the estradiol groups had eight fewer hot flushes per day on average compared to the start of the study. The reduction in the placebo groups was four to six fewer flushes.
Women given three or two sprays of estradiol showed significant reductions in symptom severity at 4 and 12 weeks compared with women given the placebo. Women treated with one spray of estradiol showed a significant reduction in symptom severity at 5 weeks only.
Adverse events were mild and on par with what has been seen with other transdermal products, the authors note.
The results suggest that this new spray “will be an attractive first choice for transdermal estradiol delivery,” the authors conclude.
SOURCE: Obstetrics & Gynecology, June 2008.
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