Elestrin estradiol gel 0.06%

About
Elestrin

Concentrated on Hot Flash & Night Sweats Relief

10 Fewer Hot Flashes Per Day By Week 12a,1,2

Ask any menopausal woman what she's looking for in an estrogen therapy and chances are the first thing she'll answer is: "Hot Flash Relief!" Elestrin delivers a significant reduction in the frequency and severity of hot flashes associated with menopause with a low dose of estrogen.2 Today, associations such as the US Food and Drug Administration (FDA), North American Menopause Society (NAMS), and American College of Obstetrics and Gynecologists (ACOG) advise that hormone therapy should be given at the lowest dose that helps, for the shortest time needed.3-5

In a 12-week, placebo-controlled, clinical trial of 484 postmenopausal women who were experiencing, on average, 93 moderate-to-severe hot flashes per week at the start of study, Elestrin delivered significant benefits:

  • Fewer Hot Flashes & Night Sweats
    • Daily average hot flashes were reduced from 13 to 3 by the end of the study with the 2-pump dosea,b,1,2, and:
      • About 40% of women were hot-flash-free2
      • 76% of women taking Elestrin reported great improvement in their hot flashes2
    • Daily average hot flashes were reduced from 13 to 5 by the end of the study with the 1-pump dose and from 13 to 8 with placebo1
  • Less Severe Hot Flashes & Night Sweats
    • The 2-pump dose of Elestrin significantly reduced the severity of hot flashes by week 4; the 1-pump dose, by week 5c,1,2

a In a 12-week clinical trial with the 2-pump (1.7g) per day dose

b 2-pump dose = 1.7 grams/day; 1-pump dose = 0.87 grams/day

c Severity assessed on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) with baseline severity of
  2.4 in all treatment groups.

d Average number of hot flashes per day across treatment group

All estrogen therapy has risks. Please see important safety information at the bottom of this page.

Indication

Elestrin is indicated for the treatment of moderate-to-severe hot flashes and night sweats associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia (decline in memory or thinking skills). Estrogen and progestin therapy has shown an increased risk of breast cancer, heart attack, and blood clots. Estrogen therapy, with or without progestins, increases the risk of stroke and dementia. Estrogen therapy alone increases the risk of cancer of the uterus (womb).

Elestrin should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past; currently have or have had blood clots; currently have or have had liver problems; or think you may be or know that you are pregnant.

The most frequently reported adverse events in clinical trials were nose and throat irritation, breast tenderness, upper respiratory tract infection, and irregular menstrual bleeding.

You and your healthcare provider should discuss whether Elestrin is right for you or whether you still need treatment with Elestrin.

Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

References

  1. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  2. Simon JA, Bouchard C, Waldbaum A, et al. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women. Obstet Gynecol. 2007;109:588-96.
  3. US Food and Drug Administration Web site. Available at: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Accessed July 20, 2010.
  4. American College of Obstetrics and Gynecology Web site. Available at: http://www.acog.org/from_home/publications/press_releases/nr10-01-04.cfm. Accessed July 20, 2010.
  5. North American Menopause Society updates guidelines on postmenopausal hormone therapy. Available at: http://cme.medscape.com/viewarticle/576970. Accessed July 20, 2010.