Estrogen and Estrogen with Progestin Therapies
for Postmenopausal Women

The Food and Drug Administration has received requests from the public to provide updated product information for estrogen- and progestin-containing drug products used for treating postmenopausal symptoms. Information from the Women’s Health Initiative (WHI) trial about estrogens and progestins continues to have significant public health implications for postmenopausal women. As the series of new study results from the WHI become available, we are encouraging manufacturers to update their labels for estrogen- and progestin-containing drug products for postmenopausal women to include new information from these studies. This information will allow individuals to understand the risks and benefits of these products and make appropriate health care decisions. This web page lists products with approved updated labeling that includes the important information from the WHI studies.

 On May 31, 2002, the WHI study of conjugated estrogens 0.625 mg/day, plus medroxyprogesterone acetate 2.5 mg/day in postmenopausal women was stopped after a mean of 5.2 years of follow-up because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits.  Data on the major clinical outcomes through April 30, 2002, regarding increased risks for invasive breast cancer, heart attacks, strokes, and venous thromboembolism rates, including pulmonary embolism, became available July 17, 2002.  These data were updated March 17, 2003.  The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI, recently concluded that women treated in the study with conjugated estrogens 0.625mg combined with medroxyprogesterone acetate 2.5mg have a greater risk of developing probable dementia than those on placebo.   

Detailed information about the Women's Health Initiative and the Women's Health Initiative Memory Study is available at the National Institute of Health's Menopausal Hormone Replacement Information web site www.nih.gov/PHTindex.htm.

Updated Labeling for Estrogen and Estrogen-Progestin Products for Postmenopausal Women*

*The following products have FDA-approved labeling that includes information from WHI studies.  Not all of the WHI studies are completed yet.  As more information becomes available, labeling for these products will be updated and added to this site.

• Alora (estradiol transdermal system)
• Climara (estradiol transdermal system)
• Climara Pro (estradiol/levonorgestrel transdermal system)
• Delestrogen (estradiol valerate injection)
• Enjuvia (synthetic conjugated estrogens; B)
• Estraderm (estradiol transdermal system)
• Estrasorb (estradiol topical emulsion)
• femhrt (norethindrone acetate/ethinyl estradiol tablets)
• Prefest (estradiol/norgestimate) Tablets
• Premarin (conjugated estrogens tablets)  
• Premarin Intravenous (conjugated estrogens, USP for injection)  
• Premarin Vaginal Cream (conjugated estrogens) 
• PREMPRO/PREMPHASE (conjugated estrogens/medroxyprogesterone acetate tablets)
• Vivelle (estradiol transdermal system)
• Vivelle-Dot (estradiol transdermal system)

 FDA Press Releases

• FDA Plans to Evaluate Results of Women's Health Initiative Study for Estrogen-Alone Therapy.  FDA Talk Paper  (Posted 3/2/2004)
• FDA Updates Hormone Therapy Information for Post Menopausal Women. FDA Press Release.  [En Espanol]  (Posted 2/10/2004)
• FDA approves Estrasorb (estradiol topical emulsion) for the treatment of menopausal hot flashes.  FDA Talk Paper. (Posted 10/10/2003)
• FDA launches a collaborative campaign to inform women about menopausal hormone therapy. FDA News. (Posted 9/9/2003)
• May 27, 2003 FDA Statement on the Women's Health Initiative Memory Study (WHIMS)
• FDA Approves Lower Dose of Prempro, a Combination Estrogen and Progestin Drug for Postmenopausal Women  (Posted 3/14/2003)
  • Approval Letter  
• FDA Fact Sheet: New Advice to Postmenopausal Women
• FDA Talk Paper on the Issuance of a Federal Register notice concerning estrogen/androgen combination products (Posted 4/11/2003)
• FDA Statement on the Results of the Women's Health Initiative (Posted 8/13/2002)

Guidances for Industry

• Federal Register; Notice of Availability. [TXT] [PDF]

• Draft Guidance: Labeling Guidance for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Prescribing Information for Health Care Providers and Patient Labeling.  [Word] or [PDF] (2/10/2004)

• Draft Guidance: Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation.  [Word] or [PDF]

 Consumer Information

• Questions and Answers for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women   (4/19/2004)

• Patients are Asking:  New Labeling and Advice on Hormone Therapies for Postmenopausal Women. From FDA Patient Safety News; links to video.  (Posted 3/18/2003)
• FDA Fact Sheet: New Advice to Postmenopausal Women
• The Estrogen and Progestin Dilemma: New Advice, Labeling Guidelines.  From FDA Consumer magazine, March -April, 2003.  (Posted 3/17/2003)
• Fact Sheets and purse guides from FDA:
  Menopause and Hormones
  • Fact Sheet [HTML] or [PDF] 
  • Purse Guide [HTML] or [PDF]
  • En Español - La menopausia y las hormonas
    Fact Sheets [HTML] or [PDF]
    Purse Guides [HTML] or [PDF]

Other Resources for Women’s Health Information

• FDA Office of Women's Health
  Menopause and Hormone Therapy. The Office on Women's Health, U.S. Department of Health and Human Services Office: The National Women's Health Center.
• Women's Health Initiative, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI),
• Hormone Replacement Therapy. U.S. Preventive Services Task Force, Update, 2002 Release.
• Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women. JAMA, July 17, 2002; 288(3): 321-333. Abstract
• Estrogen Plus Progestin and the Incidence of Dementia and Mild Cognitive Impairment in Postmenopausal Women: The Women's Health Initiative Memory Study: A Randomized Controlled Trial, JAMA, May 2003; 289(20): 2651-2662. Abstract 9 No. 20, May 28, 2003

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Date created: January 8, 2003; Date updated: June 8, 2004

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