Hormone replacement therapy continues to be used by thousands of women who are entering menopause. While many of the health claims that have surrounded hormone replacement therapy have been exaggerated in the past, there are still benefits for the relief of menopausal symptoms. Many women choose to have their hormone replacement therapy made by a compounding pharmacy to control their dosing and to ensure the formulation does not include excipients to which they may be sensitive.
Reasons that Women Take Hormones
The main symptoms of menopause that lead women to seek out hormone replacement therapy are sleep disturbances, mood changes, sexual dysfunction, hot flashes and night sweats (also called vasomotor symptoms), and cognitive decline. Primarily, hormone replacement is indicated for treating vasomotor symptoms of menopause. About 3 out of every 4 women will experience these symptoms when they enter menopause. There are lifestyle changes that can ease these symptoms and doctors can help women make changes that alleviate some of them. However it is likely that these symptoms will continue to arise even if they are less frequent with lifestyle changes like a healthy diet, exercise, and quitting smoking.
How Are Hormones Administered?
Estrogen can be taken orally, applied in a transdermal cream, and used in a subcutaneous pellet. Commercially available forms of hormones include creams, vaginal rings, patches, sprays, and more. Our compounding pharmacy makes hormone replacement therapy in the form of creams. We find this is the most effective and easiest way to administer the hormones. Transdermal administration minimizes the risk of blood clotting as hepatic metabolism is bypassed. You may find that a commercially available drug form works better for you such as a vaginal ring, which is not typically compounded.
Progesterone and Estrogen
At menopause, the production of hormones significantly decreases and the balance of hormones fluctuates. Progesterone is generally prescribed along with estrogen to prevent estrogen dominance and endometrial hyperplasia. There are certain low-dose estrogen creams that are used alone – for example estriol administered intra-vaginally. Estrogen and progesterone have been made in a few different ways but generally are synthetic drugs like most drugs that are prescribed.
Women may be prescribed other medications or hormones in conjunction with progesterone and estrogen. For example, although testosterone is often thought of as only a male hormone, it is actually also an important hormone for women. A compounding pharmacy can make a formulation that includes estrogen, progesterone, and testosterone in one combination. Testosterone has been associated with sexual functioning and libido in women.
Safety of Compounded Hormones
There has been a lot of discussion around the safety of compounded hormones. It is true that the drugs produced by a compounding pharmacy are not FDA approved. They are in fact exempt from the FDA approval process based on a provision in the Federal Food Drug & Cosmetic Act (FDCA). Sections 503A and 503B allow compounding pharmacies to make drugs in regulated facilities using certain high compounding standards without requiring FDA approval of every drug they make.
Compounding pharmacies must adhere to high quality standards. They are regulated by state boards of pharmacy and are subject to inspections by their respective regulatory authorities. The quality and consistency of the product is maintained through rigorous standards that can approach those of a manufacturer.
You should always discuss your treatment with your doctor to make sure you are minimizing risks. Some studies have shown that hormone replacement is most effective with fewer side effects when initiated within 10 years of the onset of menopause. After 10 years, it has been shown to have a greater risk of side effects. There are also contraindications to taking hormones for menopausal symptoms including having a history of hypertension, gallbladder disease, stroke, heart attack, and other conditions.