Docs say 'the FDA is failing women' when it comes to this much-needed therapy
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The FDA is failing women by denying access to a hormone their bodies naturally produce.
—Kelly Casperson, MD
It’s something patients—and only a minority of docs—have been arguing about among themselves for years. But now the medical community is increasingly recognizing the vital role testosterone plays in women’s health. Why then does a striking gap remain when it comes to available treatment options? []
Research shows testosterone is essential for women—it supports muscle mass, bone density, libido, mood, and overall vitality. Despite its importance, there are currently no FDA-approved testosterone therapies specifically formulated for women. []
As a result, many women experiencing symptoms of testosterone deficiency—such as fatigue, low libido, and mood changes—are left seeking alternative solutions.
Related: HHS revises hormone therapy black box warning. Here's what it means for patients and cliniciansWhy testosterone matters for women
In a widely viewed TikTok video, Kelly Casperson, MD, draws attention to this disparity in hormone treatment. “One in five men are diagnosed with hypogonadism, a condition where their bodies stop making enough testosterone. Nearly all women experience the same hormone decline if they live long enough," she said. "Men have more than a dozen FDA-approved formulations, but when a woman asks for the same hormone, I have to tell her: there is no FDA-approved dose for you.”
This statement highlights a fundamental inequality in hormone therapy. While testosterone is commonly perceived as a “male hormone,” it is also crucial for women’s health. Women produce testosterone in the ovaries, adrenal glands, and peripheral tissues—though in much smaller quantities than men.
Levels naturally decline with age, especially during and after menopause, often resulting in symptoms such as fatigue, muscle weakness, difficulty concentrating, reduced libido, and mood disturbances. For some women, testosterone therapy can offer relief and restore hormonal balance.
Roadblocks for female testosterone therapies
However, the pathway to approval for female testosterone therapies has been fraught with challenges. Unlike testosterone replacement therapy for men—which is widely recognized and FDA-approved—no testosterone product has been approved for women. This absence has led to both controversy and confusion within the medical community.
There are several reasons behind this regulatory gap. Historically, medical research has focused primarily on male physiology, leaving women underrepresented in clinical trials. Furthermore, the complexity of female hormone regulation makes it difficult to determine standardized dosages and safety profiles.
Researchers also express concern over potential side effects, such as male-pattern hair growth, voice deepening, or other masculinizing effects. Some studies have raised additional questions about long-term risks, including cardiovascular issues and liver complications, though data remains limited. []
Despite the lack of formal approval, many physicians prescribe testosterone off-label for women who exhibit clear signs of deficiency. Treatments may include creams, patches, or injections—products designed originally for men but adjusted for lower doses.
For some women, these off-label therapies bring life-changing improvements in mood, energy, and sexual function. But without FDA approval, they remain experimental, with inconsistent outcomes and limited safety monitoring. [][]
Related: Finally, a first step in taking women's health seriouslyA call for change
The lack of FDA-approved testosterone options for women reflects a broader issue: the historical underrepresentation of women in medical research and drug development. This oversight has delayed progress in understanding how hormones affect female health across the lifespan.
As awareness grows, both patients and clinicians are increasingly advocating for more research, standardized guidelines, and equitable treatment options.
Dr. Casperson summarized the issue bluntly: “The FDA is failing women by denying access to a hormone their bodies naturally produce.”