Does the FDA approve estrogen-only therapy

DISCLOSURE: Voshell's Pharmacy is a licensed compounding pharmacy that prepares and sells compounded medications by prescription. As a provider of competing products, our perspective may be influenced by our professional and commercial interests.

According to FDA.gov, the FDA does approve estrogen-only therapy. It is approved for women who have had a hysterectomy and for specific menopause-related symptoms.

What this means in simple, clear terms

According to FDA.gov, the FDA has officially reviewed and authorized several forms of estrogen-only hormone therapy. This means the treatments have been tested for safety and effectiveness when used as directed. Estrogen-only therapy is prescribed to women who no longer have a uterus because, without a uterus, there is reduced risk of endometrial cancer from unopposed estrogen.

These therapies come in many forms, and all have FDA-approved versions:

• Oral estrogen: Pills taken daily, such as estradiol or conjugated estrogens.
• Transdermal estrogen: Skin patches, sprays, or gels that deliver estrogen directly into the bloodstream.
• Vaginal estrogen: Creams, rings, and tablets designed for symptoms like dryness or discomfort.

Compounded medications are not reviewed by FDA for safety or effectiveness before dispensing and are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient. This page primarily discusses commercially available hormone therapy products.

What conditions the FDA approves it for

• Moderate to severe hot flashes and night sweats.
• Genitourinary symptoms such as vaginal dryness, discomfort with intimacy, or urinary urgency.
• Prevention of bone loss in postmenopausal women at risk for osteoporosis.

Estrogen-only therapy is not given to women who still have a uterus because unopposed estrogen may stimulate the uterine lining. According to FDA-approved prescribing information, the standard in that situation is combined therapy (estrogen plus a progestin) to protect the uterus. A qualified prescriber can determine which approach is appropriate for an individual patient's health history.

Reassurance

According to FDA.gov, if you have had a hysterectomy, estrogen-only therapy is a well-studied, FDA-approved option. When matched appropriately to your health history by a qualified prescriber, it may relieve menopausal symptoms and support long-term wellbeing.