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Home » Drug Information » FDA Approved Drugs » 2004
Medical Areas: Obstetrics/Gynecology (Women’s Health) | Family Medicine

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EstroGel (estradiol gel 0.06%)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Solvay Pharmaceuticals
Approval Status: Approved April 2004
Treatment Area: Menopause

General Information

EstroGel is a topical gel containing 0.06% estradiol in an absorptive hydroalcoholic gel base, formulated to provide a controlled release of the hormone. It is designed to treat symptoms associated with menopause.

It is specifically indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, including hot flashes. It is also indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause, especially when the atrophy is concurrent to vasomotor symptoms.

The recommended topical dose of EstroGel is 1.25 g once daily, delivered via metered pump. Recommended application is to the posterior surface of the arm, from the back of the wrist to the shoulder.

Clinical Results

FDA approval of EstroGel for the treatment of monopausal vasomotor symptoms was based on a double-blind, placebo-controlled study enrolling 145 women between 29 and 67 years of age. Subjects received either 1.25g EstroGel (n=72) or placebo (n=73) once daily for 12 weeks. Primary endpoint efficacies, measured by reduction in the occurrence of moderate-to-severe hot flashes and reduction in severity of hot flashes, were assessed at 4, 8, and 12 weeks. Results showed that EstroGel produced a statistically significant decrease in both the number and severity of hot flashes at 4 and 12 weeks (reduction at 8 weeks was not significant). Specifically, at 4 weeks, subjects receiving EstroGel experienced 0.85 fewer hot flashes per day, and a reduction in severity score of 0.32; at 12 weeks, EstroGel subjects experienced 1.71 fewer hot flashes and a severity score reduction of 0.49.

FDA approval of EstroGel for the treatment of vulvar and vaginal atrophy was based on results of vagina wall cytology examinations performed on all subjects at 12 weeks. A significant increase in superficial epithelial cells was observed for the EstroGel group; no significant increase was seen among the placebo group.

Side Effects

Adverse events associated with the use of EstroGel may include (but are not limited to) the following:

  • Infection
  • Abdominal Pain
  • Diarrhea
  • Weight Gain
  • Pap Smear: Suspiscious
  • Metrorrhagia
  • Vaginitis
  • Pruritus

Mechanism of Action

EstroGel supplies systemic estradiol, the primary estrogenic hormone secreted by the human ovaries, which is lost during and following menopause. Estradiol binds to widely distributed nuclear receptors in estrogen sensitive tissues. It also acts to inhibit the pituitary release of leutenizing hormone and follicle stimulating hormone via negative feedback loop (elevated levels of these hormones are customarily observed in postmenopausal women).

Literature References

Archer DF; EstroGel Study Group. Percutaneous 17beta-estradiol gel for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2003 Nov-Dec;10(6):516-21.

Brennan JJ, Lu Z, Whitman M, Stafiniak P, van der Hoop RG. Serum concentrations of 17beta-estradiol and estrone after multiple-dose administration of percutaneous estradiol gel in symptomatic menopausal women. Therapeutic Drug Monitoring. 2001 Apr;23(2):134-8.

Additional Information

For additional information regarding EstroGel or symptoms of menopause, please contact the EstroGel Web Site