Menopause and testosterone: Treatment option or justified taboo?

madman

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* However, he noted there is still hope for the industry as Marius is currently developing an oral testosterone treatment for women.

“Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”



Medical experts say that boosting testosterone levels can improve menopause symptoms, but awareness of the treatment is still low.



Where is the FDA approval?

While experts say there is no singular reason that testosterone has not been approved by the FDA for women’s use, discourse around its safety profile in men has been cited as a potential factor.

Shalin Shah is CEO of Marius Pharmaceuticals, the company that creates the only FDA-approved oral testosterone treatment for men.


Shah pointed to a number of studies in the mid-2010s that linked the increase in testosterone levels in men with non-fatal myocardial infarction, where blood flow to a portion of the heart muscle is blocked.

“At that time, the FDA changed the labels on testosterone and added a cardiovascular risk warning,” he said.

Ultimately, this had an impact on the safety profile of testosterone. While studies around the hormone and its use in women were still being conducted, it wasn’t approved as a treatment option for this patient population.

However, the narrative around testosterone began to change in 2023.

That year, a New England Journal of Medicine study involving over 5,200 men found that testosterone replacement therapy does not increase the risk of major adverse cardiovascular events in men with low testosterone.

This was a win for those in the testosterone treatment space and led the FDA to remove the black box label for the treatment in February of this year.

Despite this development, Shah said there is still not much attention around the decision to remove the risk profile connected to testosterone.


“There’s a gap in the traditional media talking about the benefits of hormone therapy for the benefit of patients,” he said.

However, he noted there is still hope for the industry as Marius is currently developing an oral testosterone treatment for women.

“Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”
 
 
 

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Understanding Your Hormones

Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

DHT

Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

Free Testosterone

The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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