What are the exogenous hormone therapy recommendations for a 60-year-old female with ovaries, cervix, and uterus intact?

From the Guidelines

For a 60-year-old female with intact ovaries, cervix, and uterus, hormone therapy (HT) should be used with caution and only for the management of moderate to severe menopausal symptoms, such as hot flashes and vaginal dryness, due to the associated risks of cardiovascular disease, stroke, and breast cancer, as recommended by the USPSTF 1.

Key Considerations

• The USPSTF recommends against the use of combined estrogen and progestin for the prevention of chronic conditions in postmenopausal women, as the benefits do not outweigh the harms 1.
• The use of estrogen alone in women with an intact uterus increases the risk of endometrial cancer, making the addition of progestogen necessary to protect the endometrium 1.
• Treatment should be at the lowest effective dose for the shortest duration needed to manage symptoms, typically reassessed annually.
• A thorough discussion of personal and family medical history, risk factors, and treatment goals should occur before initiating therapy.

Hormone Therapy Regimens

• A typical regimen would be oral conjugated equine estrogens (0.3-0.45 mg daily) or estradiol (0.5-1 mg daily), combined with micronized progesterone (100-200 mg daily for 12-14 days per month in cyclic regimens or daily in continuous regimens) or medroxyprogesterone acetate (2.5 mg daily in continuous regimens).
• Transdermal estradiol (0.025-0.05 mg/day patch) is an alternative that may have lower thrombotic risk.

Important Notes

• The USPSTF recommendations do not apply to women who are considering hormone therapy for the management of menopausal symptoms, such as hot flashes or vaginal dryness 1.
• The safety and effectiveness of compounded bioidentical hormones have not been evaluated through the FDA's drug approval process, and their use is not recommended 1.

From the FDA Drug Label

The WHI estrogen plus progestin substudy stratified by age showed in women 50 to 59 years of age a non-significant trend toward reduced risk for overall mortality [HR 0.69 (95 percent CI, 0.44-1. 07)]. Effects on the endometrium In a randomized, double-blind clinical trial, 358 postmenopausal women, each with an intact uterus, received treatment for up to 36 months. The treatment groups were: Progesterone capsules at the dose of 200 mg per day for 12 days per 28-day cycle in combination with conjugated estrogens 0.625 mg per day (n=120); conjugated estrogens 0. 625 mg per day only (n=119); or placebo (n=119). A comparison of the progesterone capsules plus conjugated estrogens treatment group to the conjugated estrogens only group showed a significantly lower rate of hyperplasia (6 percent combination product versus 64 percent estrogen alone) in the progesterone capsules plus conjugated estrogens treatment group throughout 36 months of treatment.

For a 60-year-old female with ovaries, cervix, and uterus intact, the exogenous hormone therapy recommendations are to use estrogen plus progestin therapy, as it has been shown to reduce the risk of endometrial hyperplasia compared to estrogen alone therapy 2. The recommended dosage is conjugated estrogens 0.625 mg per day in combination with progesterone capsules 200 mg per day for 12 days per 28-day cycle 2. However, the decision to initiate hormone therapy should be based on individual patient needs and risk factors, and the lowest effective dose should be used for the shortest duration necessary to achieve treatment goals.

• Key considerations:
  • Estrogen plus progestin therapy is recommended for women with an intact uterus to reduce the risk of endometrial hyperplasia.
  • The lowest effective dose should be used for the shortest duration necessary to achieve treatment goals.
  • Individual patient needs and risk factors should be taken into account when making decisions about hormone therapy.
  • The WHI study results should be considered when evaluating the risks and benefits of hormone therapy 3.

From the Research

Exogenous Hormone Therapy Recommendations

For a 60-year-old female with ovaries, cervix, and uterus intact, the following exogenous hormone therapy recommendations are considered:

• Current guidelines recommend that hormone therapy (HT) in postmenopausal women with a uterus include a progestin to protect against endometrial hyperplasia 4.
• Conjugated estrogens (CE) combined with the selective estrogen receptor modulator bazedoxifene (BZA) is a new progestin-free HT option for alleviating estrogen deficiency symptoms in postmenopausal women with a uterus for whom treatment with progestin-containing therapy is not appropriate 4.
• Progestogens such as micronized progesterone and the synthetic progestins are defined by their ability to transform the estrogen-primed proliferative endometrium into secretory endometrium 5.
• Oral estradiol/micronized progesterone may be associated with a lower risk of venous thromboembolism compared with conjugated equine estrogens/medroxyprogesterone acetate in real-world practice 6.
• The combination of estradiol/micronized progesterone affects breast cancer-related genes much less than conjugated equine estrogens/medroxyprogesterone acetate 7.

Key Considerations

When considering exogenous hormone therapy for a 60-year-old female with ovaries, cervix, and uterus intact, the following key considerations should be taken into account:

• The risk of venous thromboembolism associated with different hormone therapy regimens 6.
• The effects of different progestogens on breast cancer-related gene expression 7.
• The potential benefits and risks of progestin-free hormone therapy options, such as conjugated estrogens combined with bazedoxifene 4.
• The importance of individualizing hormone therapy recommendations based on a woman's unique medical history, risk factors, and symptoms 5.