There are three things that guide clinical decision-making, or choices made by your doctor. These are: guidelines, evidence, and experience.
Medications can be used by their label, the FDA-approved reason for use and dose, or they can be used “off-label” which is not FDA-approved but may very well be following guidelines, evidence, experience or some combination thereof.
Guidelines are published recommendations made by medical societies (for instance, The Menopause Society, the American Heart Association, etc.). These guidelines should be based on evidence and often are, however they can also be based on “expert opinion” where a panel of professionals establishes a guideline based on their collective opinion.
Evidence is the result of clinical trials. While these may become part of published guidelines, it takes time for this to happen. A doctor may be using “evidence-based” or “evidence-informed” medicine based on sound scientific studies. If these studies have not yet been made part of guidelines, then that doctor is practicing evidence-based medicine but is not following guidelines, which is not necessarily a negative thing.
Experience is invaluable in medicine, any trade, and life. We all experience clinical situations that we will never forget and may even haunt us. We may change our clinical practice to avoid a repeat experience or simply remember the clinical steps we took in such a situation, guiding us in the future.
With that being said, let’s see where we are with testosterone use for perimenopausal and menopausal women.
There is one guideline-based indication for testosterone use in this population: hypoactive sexual desire disorder. We will discuss this below.
There is growing evidence of testosterone use in women and while more is needed, thus far the evidence is positive in my opinion.
There is certainly experience by some doctors, but not all, using testosterone in this population.
There is no FDA approved testosterone therapy for women.
This does not mean that testosterone therapy cannot be used for perimenopausal and menopausal women, but it means this therapy would be used “off label”. As a patient, you would need to find a doctor who is practicing based on evidence and experience.
There are over 30 testosterone preparations that are FDA approved for use in men in the United States.
Because there is no approved therapy, if testosterone therapy will be used in a woman we have to cut the dose prescribed to a man (usually 1/10th the dose).
Why would testosterone be used in menopausal women?
Testosterone is a hormone under the umbrella of androgens that we typically think of as male hormones. Our ovaries, however, produce testosterone throughout our reproductive lives. With menopause and the loss of ovarian function, testosterone levels decline in addition to estrogen.
Testosterone can benefit bone health, vasomotor symptoms (hot flashes and night sweats), brain health, and energy levels. This is in addition to sex drive.
It has been studied to benefit Hypoactive Sexual Desire Disorder (HSDD) which is a distressing loss of interest in sex, affecting 10% of women. Testosterone therapy in this setting can result in increased satisfying events, arousal, and orgasm. This indication, while not FDA approved, is recognized and recommended by multiple medical societies (so prescribing for this reason would be consistent with guidelines). In Australia, there is an approved testosterone therapy for women for this indication.
Testosterone has also been shown to improve lean muscle mass and performance of activities such as chest-press and stair climbing. This is a massively important factor in longevity and aging well.
A very important and promising benefit that we are gaining knowledge about is bone density improvement. Studies have shown improvement in bone mineral density and decreased risk of hip fracture in patients using testosterone. Again, another hugely important factor for aging women.
Why isn’t there an FDA approved therapy?
Though there is an increasing number, overall studies have been scant on testing testosterone use in women.
What information do we still not have?
We still do not have a clear understanding of the best route of delivering testosterone (cream, patch, pellet). In theory, the best route would relieve symptoms and maximize benefit while minimizing side effects and risks. The best way to assess this is to design a “head to head” trial, meaning one group gets pellet testosterone, another gets patch testosterone, and these groups are compared.
What are potential risks?
Risks of testosterone therapy include acne and unwanted hair growth. Irreversible risks such as voice deepening typically occurs when testosterone levels are above the normal female range.
There is concern and question over risk of abnormal lipid profiles (cholesterol) and cardiovascular risks as well as risk of hormone-sensitive cancers like uterine or breast.
Studies looking at lipid profiles when using testosterone are basically all over the place, including some that showed improved profiles. While that doesn’t entirely reassure us that testosterone could improve a lipid profile, there isn’t convincing evidence that it’s detrimental to the lipids as it was once thought.
It does not appear that testosterone increases blood pressure or convincingly any cardiovascular outcome. To the contrary, there may be some benefit to heart health from using testosterone based on evidence that showed improved muscle strength, body fat mass and insulin resistance.
To my knowledge, there are no studies showing an increase in hormone-sensitive cancers in patients who use testosterone therapy.
Because testosterone hasn’t been extensively studied in women, there’s room for more convincing evidence as to benefits, risks, and best route of delivery. Hopefully now with more attention than ever on menopause, these outcomes will become more clear and women can benefit from use of testosterone.
Resources:
Some of the information contained in this article is the result of my training, medical knowledge, and personal experience without a specific source to be cited.
This is not medical advice.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9133974/
https://menopause.org/wp-content/uploads/professional/practice-pearl-testosterone_.pdf
