The Testosterone Gap: Why Midlife Women Are Still Waiting

I’ve been lifting weights since I was about 13. I share that to say that I’m not new to weight lifting, so a few years ago, when lifting half of what I was used to lifting started hurting my joints, I knew something was wrong. I had been using estrogen and progesterone for about six months and was seeing wonderful results. After consulting with my hormone-certified provider, we decided it was time to add testosterone. But I was very surprised by what I found.

While estrogen and progesterone are both FDA-approved and covered by insurance, testosterone is not, at least not for women. Men have a whole shelf of FDA-approved testosterone options — gels, patches, injections, pellets. There is currently no FDA-approved product for women. This isn't because testosterone isn’t applicable for women. It's due to drug approval, research funding, and outdated assumptions about female physiology.

So let’s talk about what's actually going on, what the evidence supports, and what's realistic for you to expect from testosterone therapy.

Testosterone isn't just a "male" hormone

Testosterone is actually the most abundant biologically active hormone in a woman's body throughout her life, even more abundant, by concentration, than estrogen. It's made in the ovaries and adrenal glands, and it plays a role in libido, energy, mood, muscle mass, bone density, and cognitive function. As women move through perimenopause and menopause, testosterone levels decline alongside estrogen and progesterone, though the drop tends to be more gradual and starts earlier, often in the mid-30s to 40s.

Where the evidence is strongest: low libido

The best-established, most rigorously studied use of testosterone in women is for hypoactive sexual desire disorder (HSDD) — a persistent, distressing loss of sexual desire — in postmenopausal women. 

In 2019, a Global Consensus Position Statement on testosterone therapy for women was published and endorsed by more than a dozen major medical societies. It concluded that physiologic-dose testosterone therapy is a reasonable, evidence-supported option for postmenopausal HSDD, with a favorable safety profile at doses that mimic normal premenopausal female levels. The Menopause Society reaffirmed this in a 2023 practice guidance, and more recent research (including cardiovascular safety data published in 2023) has continued to support that transdermal testosterone (creams and gels) at physiologic doses doesn't appear to raise cardiovascular risk or negatively affect breast tissue.

Anecdotal evidence matters but is not being heard

Many women using testosterone report relief of symptoms outside of HSDD, including improvement in mood and brain fog, bone density, lean muscle mass, joint comfort, and overall vitality. Science backs this anecdotal evidence as testosterone plays a documented role in muscle protein synthesis and bone maintenance, so a connection to joint health and an increase in the ability to lift heavier, is understandable. 

But my experience is just that, my own experience. These broader benefits don’t yet have the same weight of large-scale clinical trials. Frustratingly, the trials are not happening and yet 50% of the population will encounter low testosterone issues once they reach perimenopause and menopause.

Why are there no FDA-approved products for women?

Just a few factors include:

  • Regulatory “chicken-and-egg” scenario. FDA approval requires large, expensive Phase 3 trials designed specifically for the female indication and dose. Pharmaceutical companies have been reluctant to fund that work without a clear approval pathway, and there's been no clear pathway without the trial data.

  • Lack of Financial Incentive: Large-scale safety trials cost hundreds of millions of dollars. Because doctors can already prescribe male testosterone formulations off-label at a 1/10th dose, or use custom compounding pharmacies, pharmaceutical companies face less financial incentive to fund the massive trials the FDA demands. And because women use the compounding pharmacies, the results are not being reported regularly to the FDA.

  • Unfounded Fear. Some of the reluctance traces back to older, higher-dose formulations and outdated fears about masculinizing side effects or cancer risk that more recent, lower-dose research hasn't borne out.

However, things might finally be shifting. In January 2026, the FDA provided formal development-pathway guidance to a biopharmaceutical company working on a novel, structurally modified testosterone therapy designed specifically for women. It's not an approval, but hopefully it's a meaningful step forward.

What does all of this mean?

Because there's still no FDA-approved product, testosterone therapy for women in the U.S. is currently off-label, meaning it's prescribed by physicians using their clinical judgment, typically through compounding pharmacies or by carefully dosing down male-approved products. If you're considering testosterone, it is important to have a conversation with a provider who is trained in the use of hormones and will listen to you about the symptoms you are experiencing. It is also important to get a baseline blood test before starting testosterone therapy and monitor your hormone levels moving forward.

I’m here to help

I'm not a medical professional and I'll never be the one deciding whether testosterone is right for your body. But I know firsthand how disorienting it is to feel your body changing and not have a clear map for why, or a sense of what's worth exploring versus whatever the latest internet craze is. That's my function as an integrative health coach. I help you separate the signal from the noise, get clear on what you're actually experiencing, prepare good questions for the right kind of appointment, and help you build the daily habits — strength training, nutrition, stress and sleep support — that make any hormonal intervention work better for you.

If you're in perimenopause or menopause and wondering how to move forward, I'd love to talk. Reach out today so we can figure out your next step together.

This post is educational and not a substitute for personalized medical advice. My own experience with testosterone is exactly that: my own. If you're curious whether it might be right for you, the best next step is a conversation with a menopause-informed healthcare provider who can evaluate your full hormonal picture.

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