What is the protocol for Hormone Replacement Therapy (HRT) treatment?

From the Guidelines

The protocol for Hormone Replacement Therapy (HRT) treatment should prioritize the use of transdermal 17β-estradiol (17βE) with a progestin, such as medroxyprogesterone acetate (MP), in a sequential or continuous combined regimen, with the goal of minimizing side effects and maximizing benefits, as recommended by the most recent study 1.

When initiating HRT, the following steps should be taken:

• Initial evaluation: Blood tests to check hormone levels and overall health.
• Estrogen therapy: Start with a low dose of 17βE, such as 50-100 μg transdermally via patches, or 0.5-1 mg via vaginal gel, and adjust the dose based on response and blood levels.
• Progesterone: Add a progestin, such as MP, in a sequential or continuous combined regimen, with doses depending on the estrogen administered, such as 200 mg of oral MP for 12-14 days per month.
• Regular monitoring: Blood tests every 3-6 months to check hormone levels and adjust dosages.
• Long-term care: Annual check-ups to monitor overall health and assess continuation of therapy.

The choice of progestin should be guided by the patient's individual needs and medical history, with MP being the first choice due to its lower risk of cardiovascular disease and venous thromboembolism, as reported in recent studies 1.

It is essential to note that HRT should be individualized, and the decision to start or continue therapy should be based on a thorough discussion of the benefits and risks, as well as the patient's personal preferences and medical history, as emphasized in previous studies 1.

In patients with a history of cancer, particularly those who have undergone total body irradiation or survived Hodgkin lymphoma, a strict follow-up is necessary, including promotion of breast self-examination and annual imaging from the age of 25 years onwards, as recommended in the most recent study 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Dosage and Administration for testosterone gel, 1.62% differs from testosterone gel, 1%. For dosage and administration of testosterone gel, 1% refer to its full prescribing information. (2) Prior to initiating testosterone gel, 1. 62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range. (2) Starting dose of testosterone gel, 1.62% is 40.5 mg of testosterone (2 pump actuations), applied topically once daily in the morning. (2. 1)

Dose adjustment: Testosterone gel, 1.62% can be dose adjusted between a minimum of 20. 25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations). The dose should be titrated based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment.

The protocol for Hormone Replacement Therapy (HRT) treatment with testosterone gel, 1.62% involves:

• Confirming the diagnosis of hypogonadism by measuring serum testosterone levels on at least two separate days
• Starting with a dose of 40.5 mg of testosterone (2 pump actuations) applied topically once daily in the morning
• Adjusting the dose between 20.25 mg and 81 mg based on pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment
• Applying the gel to clean, dry, intact skin of the upper arms and shoulders
• Avoiding application to other parts of the body, including the abdomen, genitals, chest, armpits, or knees
• Washing hands immediately with soap and water after applying the gel and covering the application site with clothing after the gel has dried 2 2

From the Research

Protocol for Hormone Replacement Therapy (HRT) Treatment

The protocol for HRT treatment involves several considerations, including the type and dose of estrogen, the addition of progesterone, and the individualization of therapy based on patient risk factors and symptoms.

• The use of transdermal patch estrogen formulations is becoming more common due to their potential for fewer adverse effects and greater efficacy compared to oral estrogen therapy 3.
• Low-dose HRT regimens have been shown to be effective for the treatment of vasomotor symptoms and prevention of bone loss, with fewer side effects compared to high-dose regimens 4, 5.
• The decision to add a progestogen to the regimen is well accepted, particularly in women with an intact uterus, to protect the endometrium from hyperplasia 3, 6.
• The management of common estrogenic and progestogenic adverse effects is important in improving patient compliance 6.
• The use of the lowest effective dose of steroids in HRT is recommended, with low-dose regimens appearing to induce fewer side effects and potentially being safer 7.

Key Considerations

• Patient risk factors and symptoms should be taken into account when individualizing HRT therapy 3, 6.
• The type and dose of estrogen, as well as the addition of progesterone, should be carefully considered 4, 5.
• Regular monitoring and evaluation of the risk-benefit ratio of HRT is necessary, particularly in women using low-dose preparations 7.
• The use of bone densitometry and biochemical markers of bone turnover is mandatory in women using low-dose HRT preparations 7.