From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
For post-menopausal women starting compounded estrogen and progesterone cream, a typical initial dose is 2.0-3.0 mg of Bi-est (80:20) with 100 mg of compounded oral progesterone, as this range was studied in a randomized clinical trial 1. The cream should be applied once daily to thin-skinned areas like the inner wrist, inner arm, or inner thigh, and rotated between application sites to prevent skin irritation.
- Start with the lower dose and titrate upward based on symptom relief and tolerability, with clinical reassessment after 4-6 weeks.
- Women with an intact uterus must always use progesterone alongside estrogen to protect against endometrial hyperplasia.
- These compounded formulations allow for personalized dosing but lack the standardization of FDA-approved products.
- Transdermal application bypasses first-pass liver metabolism, potentially reducing side effects compared to oral formulations.
- Treatment should be used at the lowest effective dose for the shortest duration necessary to manage menopausal symptoms, with periodic attempts to discontinue or reduce dosage to minimize long-term risks, as suggested by recent reviews of hormone therapy in menopause 2. The pharmacokinetics of compounded hormones have been compared to conventional hormonal preparations, showing lower levels of estrogen with compounded hormones 1, but the clinical efficacy and tolerability of compounded bioidentical hormone replacement therapy have been reported to be favorable in some studies 3, 4.
- However, the lack of standardization and regulation of compounded hormones is a concern, and more research is needed to fully understand their effects and optimal dosing.
- The REPLENISH phase 3 study is an example of an ongoing effort to develop and evaluate a novel oral formulation of solubilized 17β-estradiol and natural progesterone combined in a single gelatin capsule 5.