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Why Isn’t Testosterone FDA-Approved to Treat Menopause Symptoms? – SheKnows

Hormones regulate so many of the systems in your body. At times, it seems unclear exactly what each of them accomplishes, or why certain levels of particular hormones are floating around. This conversation comes up, especially around perimenopause, and even post-menopause, when specific hormone therapies can be utilized as treatments for bothersome menopause-related symptoms like hot flashes, low energy, and low libido. Estrogen is the most common hormone used in hormone replacement therapy, also known as menopausal replacement therapy, but what about testosterone? Yes, we’re talking about that hormone, the one that’s typically known as the “male” hormone.

That’s right — testosterone is found in women’s bodies (at one-tenth of the amount in men’s bodies, but still) and any people born as female. Ovaries make testosterone and technically produce it at even higher levels than estrogen. And during menopause, when the ovaries slow down in their functioning, estrogen levels lower, as do testosterone levels in the body. Just like estrogen, testosterone can be safely used as a hormone replacement therapy during menopause. Still, not many people know that, because it’s not well-studied or officially FDA-approved for women. Keep on reading for everything you didn’t know about testosterone in women, testosterone replacement therapy, and how to know if it could be the right treatment for you.

What are some of the benefits of testosterone treatment during menopause?

Testosterone has the potential to treat different menopause-related symptoms than estrogen. Here are some of its research-proven benefits.

Higher energy. Fatigue, irritability, and a decreased feeling of well-being can be symptoms of low testosterone levels in pre- and post-menopausal women, according to a 2022 article. Another study that tested testosterone’s ability to treat musculoskeletal aches and pains, medically called arthralgias, actually found that taking testosterone over a period of months did not necessarily help the pain more than placebo, but did decrease fatigue and lessen mood swings.

Libido changes. Androgens, a group of sex hormones that includes testosterone, are partially responsible for sexual desire, and androgen deficiency can lead to low libido during menopause. Research has shown that combining testosterone and estrogen therapy can result in the most improvement in libido.  

Changes in muscle mass. Anecdotally, patients I have had who are on testosterone report gains in the gym. A small 2014 study also found that the women in the study given the highest dose of testosterone had higher lean body mass and muscle strength, and had more power with chest presses and on stair climbing challenges.

Improved mental concentration. Believe it or not, menopause can affect your mental clarity, and testosterone might be able to help. Poor memory and focus can be signs of androgen deficiency, and some patients have reported greater mental clarity on testosterone therapy. 

Skin tone and texture. Some patients who have excess androgens have reported increases in acne. But a recent study reported that women taking testosterone experience improvements in the smoothness of their skin tone and texture. 

Urinary incontinence. Urinary health issues, including incontinence (bladder leakage), can be specific to pre- and post-menopause. These can be signs of a decrease in testosterone. The 2021 study intended to treat arthralgias also showed improvement in urogenital symptoms. 

Why it’s a challenge to get testosterone

In order to be covered by insurance, there needs to be a specific testosterone product for women to ask insurance to pay for, along with an FDA approval. Right now, testosterone is only able to be sold as a men’s drug, because it’s still culturally considered a “men’s hormone” and the only FDA approved indications and dosing is for men. Without an FDA approval, medications could be more expensive as not covered by insurance and therefore less accessible. The FDA is asking for more safety data, even though the men’s version of testosterone therapy doesn’t require the same level of safety data, has years of proven safety already, and the women’s version would only be one-tenth of that dose. Spoiler alert: Testosterone has been used in women since the 1940’s and we have years of safety data already.

There also may not be a rush on the FDA or pharmaceutical companies’ behalf, because testosterone is a generic medication—no one can patent it. And if you can’t patent it, you can’t make as much money selling it, so the drug companies are not going to scramble to do so or pay for a lengthy multi-year safety data research study to get a cheap medication FDA approved. 

As much as I want an FDA approved product, if you’re just going to dose the medication already available at one-tenth the dose, put a pink box on it, and make it cost 500 dollars, I’m out. 

How you might be able to get testosterone from your doctor

There are ways you can get testosterone treatment from a doctor. You may have to go to a specialist, like a urologist, because many OB/GYNs don’t regularly prescribe testosterone because they don’t have as much experience with it. 

The typical dose of testosterone given to men is about 50 milligrams a day in a gel format, and the dose given to women will be very low: 5 milligrams. Hormones are very safe medications, when you think about what types of drugs are given to people, between anxiety and depression drugs, narcotics, and the like. Hormones are one of the safest medications, in terms of risk profile, to improve quality of life.  

There are four available forms of testosterone: a topical gel, which is an FDA-approved male testosterone product that will cost about 20 dollars a month out of pocket (since it won’t be covered by insurance). A cream is another option, which is slightly more expensive. Another treatment option is an injectable, but this is less common because it is hard to measure out exactly one-tenth of the dose given to men (but you can compound it to make it easier). Testosterone pellets are another option that are implanted under the skin, but they are given at higher doses which often have more side effects, so a doctor may first recommend starting on the lower dose gel first.

Is there anyone who shouldn’t take testosterone?

Testosterone is contraindicated in pregnancy, as it could increase risk of birth defects. And anyone who already has signs of excess androgens, such as male-patterned balding or hirsutism (if you have PCOS, take note), may not be the right candidate for testosterone therapy. 

The most considerable concern over taking testosterone is usually around estrogen-related cancers. If a patient is taking aromatase inhibitors, to prevent testosterone from converting into potentially harmful estrogen, testosterone could be a safe option. But it’s an individualized conversation, and you should always check with your oncologist first before speaking with another specialist. 

In conclusion, all bodies make testosterone, but as long as it is inappropriately labeled as a “male hormone” it becomes erased from being relevant to all bodies. We need more research on its benefits and better availability on the market if we want true equality for all genders to have safe, inexpensive improvements to their quality of life through hormones.

Dr. Kelly Casperson is a urologic surgeon, author, sex educator, and top international podcaster whose mission is empowering women to live their best love lives. Kelly identified the need for better resources and developed a sex education membership that covers topics like sexual health, intimacy, mind work, and the science of desire. She combines education, humor, and candor in her podcast, “You Are Not Broken,” where she dismantles the myths people have learned and normalizes healthy, enjoyable sex worth desiring. Follow Dr. Kelly on Instagram (@kellycaspersonmd) or visit kellycaspersonmd.com.

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