What are the FDA approved indications for estrogen therapy?

Updated: Oct 16, 2018
  • Author: Janice L Bacon, MD; Chief Editor: Richard Scott Lucidi, MD, FACOG  more...
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The US FDA has approved HT for the following indications:

  • Vasomotor symptoms in menopause. HT is considered first-line therapy for these symptoms unless contraindications exist.
  • Prevention of bone loss and reduction of fractures in post-menopausal women.
  • Prevention of bone loss, and provision of health benefits for treatment of menopausal symptoms, cognition and mood and heart disease in women with premature ovarian failure, hypogonadism or early surgical menopause who have no other contraindications to HT. [124, 125]
  • Treatment of genitourinary symptoms and vulvovaginal atrophy.

The findings of older studies, such as the WHI, do not apply to younger menopausal women who have no other contraindications to HT. The failure to consider and appropriately prescribe HT to younger women with premature or surgical menopause may result in adverse events for them at older ages. [124, 125]

The use of HT for other potential benefits may be instituted following discussion of management options and exclusion of hormone contraindications. Benefits may outweigh risks for women who accept slightly more risks for the benefits.

Reappraisal of hormone dose and delivery route over time in menopausal women allows use of the lowest dose of HT to provide treatment benefits and minimize risks

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