Data: BioSante Low-Dose Estrogen Gel Works

In the face of concerns over the safety of estrogen therapy for menopausal women, BioSante says its low-dose estrogen gel shows promise.

The company Thursday released results of a phase 3 study of Elestrin, a fast-drying gel formulation of bio-identical estradiol, or the same estrogen produced naturally in women.

The 12-week, placebo-based study enrolled 484 symptomatic menopausal women to determine the lowest effective dose of the transdermal gel treatment.

More than 80 percent of women in the study who used Elestrin in a 0.87-gram daily dose reported great or moderate results in relieving symptoms like hot flashes, BioSante said.

The Food and Drug Administration approved Elestrin in the 0.87-gram dose, as well as in a 1.7-gram daily dose last December.

The 0.87-gram dose is the lowest FDA-approved dose of estradiol therapy for the treatment of moderate-to-severe vasomotor symptoms, BioSante said.

When launched later this year, Elestrin should be of immediate clinical value to practicing physicians and their patients by offering the lowest daily dose of estradiol available for treating symptoms associated with menopause, said Stephen Simes, BioSante’s president and chief executive officer. A significant potential advantage of this product is that it is 50 percent lower than the next lowest dose of estradiol currently on the market.

The Elestrin study is published in the March issue of Obstetrics & Gynecology.