What is the initial dosing for bioidentical hormone replacement therapy (BHRT) in postmenopausal women?

From the Guidelines

Bioidentical hormone therapy (BHT) in postmenopausal women should be initiated with low doses, such as estradiol 0.5-1 mg orally daily, due to the lack of strong evidence supporting its use for primary prevention of chronic conditions 1.

Key Considerations

• The USPSTF recommends against the use of menopausal hormone therapy for the primary or secondary prevention of cardiovascular disease, and there is no convincing evidence to support the use of bioidentical hormones for this purpose 1.
• The FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women, and the safety and effectiveness of these products have not been evaluated through the FDA's drug approval process 1.
• Treatment should be individualized based on symptoms, risk factors, and preferences, and the lowest effective dose should be used for the shortest possible time.

Dosing Recommendations

• For estrogen, consider starting with estradiol 0.5-1 mg orally daily, 0.025-0.0375 mg/day transdermal patch (changed twice weekly), or estradiol gel 0.25-0.5 mg daily.
• If a woman has her uterus, progesterone must be added to prevent endometrial hyperplasia, starting with micronized progesterone 100-200 mg orally daily for 12-14 days per month in a cyclic regimen, or 100 mg daily in a continuous regimen.
• For women experiencing vaginal symptoms primarily, low-dose vaginal estrogen can be used: estradiol vaginal tablets 10 mcg inserted vaginally twice weekly or estradiol vaginal ring 7.5 mcg/day replaced every 90 days.

Monitoring and Follow-up

• Regular monitoring is essential, including annual clinical evaluations and mammograms.
• Treatment should be titrated upward if needed after 4-8 weeks, and the patient should be closely monitored for any adverse effects.

From the FDA Drug Label

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. Patients should be started at the lowest dose for the indication The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms.

The initial dosing for bioidentical hormone therapy with estradiol for postmenopausal women is 1 to 2 mg daily, and should be adjusted as necessary to control presenting symptoms. The lowest effective dose should be used, and medication should be discontinued as promptly as possible. Administration should be cyclic (e.g., 3 weeks on and 1 week off) 2.

• The dose may need to be titrated to determine the minimal effective dose for maintenance therapy.
• Patients should be reevaluated periodically (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary.

From the Research

Initial Dosing for Bioidentical Hormone Therapy in Postmenopausal Women

• The initial dosing for bioidentical hormone therapy in postmenopausal women is not explicitly stated in the provided studies, but the studies suggest that the dosing should be targeted to physiologic reference ranges 3.
• A study published in 2013 found that administration of compounded transdermal bioidentical hormone therapy in doses targeted to physiologic reference ranges administered in a daily dose significantly relieved menopausal symptoms in peri/postmenopausal women 3.
• Another study published in 2011 found that randomized clinical trial data are sufficient to support the prescription of only estropipate, estradiol, and progesterone for the relief of menopausal symptoms, and that bioidentical hormones that are approved by the FDA may be preferred over standard hormone replacement because of their physiologic benefits and safety profile 4.
• A study published in 2017 found that registered bioidentical sex hormones, specifically non-oral estradiol ± progesterone, are optimal for menopausal hormone therapy, and that this combination can be considered as the optimal MHT, being safer than custom-compounded bioidentical hormones and oral conventional MHT, and having the best breast profile 5.

Hormone Combinations and Routes of Administration

• The studies suggest that different hormone combinations and routes of administration may be effective for bioidentical hormone therapy in postmenopausal women, including:

• Transdermal bioidentical hormone therapy with estriol, estradiol, progesterone, DHEA, and testosterone 3.
• Sublingual bioidentical hormone replacement therapy with estrogen combination and progesterone 6.
• Topical bioidentical hormone replacement therapy with estrogen combination and progesterone 6.

• However, the studies also suggest that the effectiveness of these different combinations and routes of administration may vary, and that more research is needed to determine the optimal approach 6, 7.