Zero FDA-approved testosterone products for women — a medical blind spot?
So I’ve been down a rabbit hole researching testosterone for women and I’m honestly shocked that there’s literally ZERO FDA-approved testosterone products specifically for women in the US. Not one. My wife is 48, going through menopause, and her energy levels are non-existent. Her libido is completely gone which is affecting our marriage. Her doc ran labs and her total T came back at 8 ng/dL which is super low even for women.
Her gynecologist basically shrugged and said she could try “off-label” compounded testosterone cream but insurance won’t cover it and there’s no standardization. Meanwhile men have like a dozen FDA-approved options. In Australia they actually have Androfeme approved specifically for women but we can’t get it here.
I’m not trying to make this political but it feels like a massive blind spot in women’s health. The research shows testosterone is important for women too – bone density, muscle mass, mood, sexual function. But pharma companies apparently haven’t bothered to do the trials needed for FDA approval because the market is “too small.”
Anyone else dealing with this? How are your doctors handling low T in women?
This is SO frustrating and you’re absolutely right. I’m a 52F and went through the exact same thing 2 years ago. My endocrinologist ended up prescribing a tiny dose of testosterone cypionate (like 10mg every 2 weeks) which is what they give men but way lower dose. It’s worked well for me but yeah, totally off-label and my insurance fought it initially. The lack of standardized dosing for women means a lot of trial and error. Started too high and got some facial hair, had to dial it back. Definitely needs monitoring but honestly it’s been life-changing for my energy levels.
I’m a nurse practitioner and this comes up constantly in my practice. The issue is that pharma companies would need to fund expensive clinical trials specifically in women to get FDA approval, and they’ve calculated that the ROI isn’t there compared to just having docs prescribe off-label. Compounded bioidentical testosterone can work great but you’re right about standardization being a problem – quality varies wildly between compounding pharmacies. Some of my patients have had good results with low-dose testosterone pellets too. The Australia approval of Androfeme really highlights how behind we are on this.
metabolic_maven – did you notice any other side effects besides the facial hair when your dose was too high? My doc just started me on compounded cream (can’t remember the percentage) and I’m nervous about getting too much. She said we’d recheck labs in 8 weeks but I don’t really know what to watch for in the meantime.
tbh this is part of a bigger pattern where women’s health issues just get ignored or undertreated. Same thing happened with ADHD meds, pain management, heart disease symptoms, all of it. The medical establishment has historically treated male physiology as the default and everything else as like a footnote. Your wife’s gyno should be more helpful than just shrugging – there ARE options even if they’re not ideal. Might be worth seeing an actual hormone specialist or functional medicine doc who deals with this regularly. They tend to be more comfortable with the off-label stuff and know how to dose it properly.