The Beginners Guide to Menopausal Hormone Therapy (MHT)

Menopausal hormone therapy (MHT) is having a moment, and patients are taking notice. With more women seeking relief for vasomotor symptoms of menopause, the demand for evidence-based conversations and clear guidance is growing. Yet, many of us were taught little about how to prescribe MHT confidently. If you’ve ever hesitated at the prospect of prescribing hormone therapy, this guide is here to help. Here we will provide you with practical steps to navigate prescribing MHT in your practice.

The Shifting Landscape of Hormone Therapy

In recent years, the tides of opinion regarding MHT have shifted dramatically. In the not-so-distant past, MHT was largely disfavored due to concerns stemming from the Women’s Health Initiative (WHI) study published in 2002. It’s critical to note, however, that the WHI was intended to assess the utility of hormone therapy for cardiovascular disease prevention, not treatment of menopausal symptoms. 

Fast forward 18 years and long-term WHI follow-up data shows no significant increase in all-cause, cardiovascular, or cancer mortality rates among women who used MHT in the initial study.

FDA Approvals and Off-Label Uses

MHT is FDA-approved for three indications:

1. Moderate to severe vasomotor symptoms (VMS) due to menopause.
2. Prevention of bone loss (though not for treating postmenopausal osteoporosis).
3. Vulvovaginal atrophy, with a preference for low-dose vaginal therapy if that is the only symptom being treated.

Off-label, MHT is often used for mood lability and sleep disturbances, though it’s essential to avoid prescribing it for chronic disease prevention like coronary artery disease or dementia.

Is Your Patient a Candidate for MHT?

Assessing whether a patient is a suitable candidate for MHT boils down to thoughtful evaluation:

1. Presence of Symptoms: Do they have bothersome VMS? If not, there may be better treatments available for their primary symptom of concern. 
2. Age Consideration: Are they under 60? Age is not an absolute contraindication to MHT but patients over age 60 will need more nuanced counseling on risks. 
3. Timing of Menopause: Did they go through menopause less than 10 years ago? This is not an absolute contraindication to MHT but patients who are more than 10 years from menopause will need more nuanced counseling on risks.
4. Risk Assessment: 
   1. Evaluate for contraindications, including unexplained vaginal bleeding, history of thromboembolic events, history of breast or endometrial cancer, or active liver disease. 
   2. Consider breast cancer and cardiovascular risk—you can use the Breast Cancer Risk Assessment Tool and the ASCVD Risk Estimator. You should consider alternatives to MHT if a patient has a moderate to high risk of breast cancer or has a high cardiovascular disease risk (>10%).  

Selecting the Appropriate Formulation

Once you have determined that a patient is a good candidate for MHT, you are ready to write a prescription. Estrogen is the primary treatment for the vasomotor symptoms of menopause. Patients who have a uterus will also need to be prescribed a progestogen for endometrial protection. 

Estrogens are available in multiple formulations including oral, transdermal, topical gels, and vaginal rings. Transdermal is preferred to mitigate thromboembolic risks and decrease the risk of symptomatic gallstone formation. The preferred form of estrogen is 17β-estradiol because this is structurally identical to the estrogen that is secreted by the ovary. Estrogen is administered continuously. 

Progestogens are available in oral or transdermal formulations. All patients with a uterus must be prescribed a progestogen for endometrial protection. Micronized progesterone is the preferred formulation because of its favorable safety profile and it is structurally identical to the progestogen that is secreted by the corpus luteum. 

The progestogen can be given daily or cyclically (10-14 days each month). Both options are safe for endometrial protection. There are pros and cons to either approach. Progestogens can cause mood issues and somnolence so some patients may prefer to limit the number of days per month they have to take this. However, if the progestogen is taken cyclically, most patients will have withdrawal bleeding that may become bothersome. Continuous progestogen regimens may be associated with a greater risk of breast cancer than cyclic regimens. Continuous progestogen regimens typically induce amenorrhea in most women. Ultimately, the choice of continuous or cyclic progestogen needs to be individualized to each patient. 

While it is not FDA-approved in the US for this use, a levonorgestrel IUD provides sufficient progesterone for endometrial protection. 

Initiating Therapy

Start with low doses of estrogen and titrate based on symptom relief. Common starting points include 0.025 mg transdermal estradiol or 0.5 mg/day oral estradiol. Standard doses of estrogen are typically 0.05 mg transdermal estradiol or 1 mg/day orally. 

Remember that patients with a uterus must also be given a progestogen for endometrial protection. Patients on very low doses of estrogen, for example, 0.014 mg transdermal estradiol, may only need a progestogen administered for 12 days every 6 months. However, on standard doses of estrogen, you could prescribe micronized progesterone 200 mg/day for 12 days per month or 100 mg daily. 

A simple regimen if you are just starting to prescribe MHT would be 0.025 mg transdermal 17β-estradiol and 100 mg daily micronized progesterone. Depending on symptom response, the estrogen dosing could be increased after about 6-8 weeks. 

Counseling Patients on Side Effects: Discuss potential adverse effects such as nausea, weight gain, and mood swings. It’s crucial to monitor for rare but serious risks, including breast cancer and thromboembolic events.

Evaluating Treatment Efficacy: MHT is highly effective in reducing VMS frequency by up to 75%. Lower doses of estrogen may take 6-8 weeks to take effect. Consider this interval when titrating doses. 

Discontinuation: Patients on MHT should be evaluated at routine intervals to ensure they have not developed any comorbidities that would be a contraindication to ongoing therapy. Consider periodic trials of lowering or discontinuing therapy, especially if treatment extends beyond age 65. There is no consensus on whether MHT should be tapered or abruptly discontinued. Symptoms may return in approximately half of patients upon discontinuation.

Key Takeaways

1. Patient Selection is Crucial: Focus on women under age 60 and less than 10 years from menopause with low-to-average risks for cardiovascular disease and breast cancer.
2. MHT Efficacy: It effectively manages bothersome vasomotor symptoms.
3. Getting Started: A straightforward regimen includes transdermal 17β-estradiol and oral micronized progesterone.

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