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Title: Low-Dose Transdermal Oestradiol Gel 0.1% Reduces Vasomotor Symptoms Across All Age Groups of Postmenopausal Women: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DE86.htm
Doctor's Guide
September 30, 2008

By Deborah Brauser

ORLANDO, Fla -- September 30, 2008 -- Low-dose transdermal oestradiol gel 0.1% reduces the frequency and severity of moderate-to-severe vasomotor symptoms across all age groups of postmenopausal women, according to a study presented here at the North American Menopause Society (NAMS) 19th Annual Meeting.

Ronald Ackerman, MD, Comprehensive Clinical Trials, West Palm Beach, Florida, and colleagues examined post-hoc analyses of the 488 women in the intent-to-treat population of a 12-week, double-blind, phase 3 trial of low-dose transdermal oestradiol gel 0.1%. The primary objective was to evaluate the effect of age and age plus treatment with low-dose transdermal oestradiol gel 0.1% on the frequency and severity of moderate-to-severe vasomotor symptoms over 12 weeks. The team reported their findings here at a poster session on September 25.

Subjects were grouped into 3 categories by age: <50 years; 50 to 59 years; and >60 years. Three dosings of low-dose transdermal oestradiol gel 0.1% were examined: 1.0, 0.5, and 0.25 g/d (separately and combined, compared to placebo).

The frequency and the severity of hot flashes were recorded daily by subjects in a self-evaluation diary. Last observation carried forward was used to calculate change from baseline, and analysis of covariance was used to produce least square means of the age and treatment variables.

The results showed that each dose of low-dose transdermal oestradiol gel 0.1% reduced both the mean daily frequency and severity of moderate to severe vasomotor symptoms from baseline in all age groups compared with placebo.

When stratified by age, women aged 50 years and over had an even greater response to all doses of the low-dose transdermal oestradiol gel 0.1% with significantly fewer (P < .05) and less severe (P < .001) moderate-to-severe vasomotor symptoms compared to age-matched placebo controls. Statistically, no significant interaction between age and treatment was identified.

Said Dr. Ackerman, "We've been studying [this product] for several years now, and it's the lowest-dose oestrogen available transdermally for the management of hot flashes. For postmenopausal women, it's important to use the lowest effectual dose of transdermal oestrogen that would cure their symptomology for the shortest period of time."

Funding for this trial was provided by Upsher-Smith Laboratories, Inc.


[Presentation title: Age Effects on the Efficacy of Divigel (Estradiol Gel 0.1%). Abstract P-25]

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