We continue to track the trending conversations shaping women’s hormone health, and each month we’ll bring you clinically relevant highlights.

Here’s what stood out in August:

✔️ Hormone Therapy (HT): Following the FDA panel, critics are raising concerns questioning whether commercialization is overshadowing clinical evidence. 

✔️ Precision medicine is getting real: Yale's landmark study on the genetics of contraceptive response highlights the current direction of precision hormone prescribing.

✔️ Commercial hormone testing & compounded “bioidenticals” challenged: BMJ analysis warns these offerings may be selling “false precision,” reinforcing the need for evidence-based standards in hormone care.

FDA Panel: What the critics had to say.

I'm sure you're aware of the FDA expert panel recommending the removal of the longstanding black box warnings from low-dose estrogen products. The case for change is compelling: A 20-year follow-up of the Women’s Health Initiative (WHI) shows no increase in deaths from breast cancer or cardiovascular disease among HT users.

When started before age 60, HT may even reduce all-cause mortality and lower the risk of heart attack or fracture. Yet, less than 4% of eligible women use HT today, leaving a care gap fueled by fear and outdated messaging.

But, not everyone agrees.

At a recent FDA advisory panel, several presenters strongly advocated for broader use of HT, but critics raised concerns about potential conflicts of interest, strong bias towards the benefits of HT without much discussion on the limitations of clinical evidence, and the lack of opportunity for public comment. The debate reflects a tension between growing enthusiasm for HT and the need for careful evaluation of individual risks. What’s missing, and urgently needed, is stronger evidence and real-world data to guide safe, personalized prescribing.

Our take is always about balance and personalization. We are all for hormones - if it's the right solution, at the right time for the right person. An individual approach, thorough assessments, and ongoing monitoring are the way to go. We're here to support you with nuanced, evidence-driven support, not hype.

The largest pharmacogenomic study on contraception to date

Earlier this year, our very own Dr. Aaron Lazorwitz and his team examined 1.8 million genetic variants in 880 women using the etonogestrel implant. The results confirmed what many of you may observe on the regular: hormone levels varied nearly 20-fold between women on the same device, explaining inter-variable side effects or rare contraceptive failures, while others do not experience side effects.

The critical caveat is that despite the scale and rigor of the study, no genetic variant reached genome-wide significance, even the usual suspects of CYP3A4/5 and hormone receptor polymorphisms. While CYP3A71C and the SEC16B locus were presented as plausible genetic leads, CYP3A71C with lower hormone levels in carriers and SEC16B with higher levels in carriers, their effect sizes were too small and allele frequencies too rare to reach statistical power.

What this means for your practice.

✔️ No actionable pharmacogenetic marker exists for the etonogestrel implant yet. Known pharmacogenetic variants, such as the “usual” PGx variants in liver enzymes, do not play a dominant role in implant pharmacokinetic variability. If variability in contraceptive response is genetically influenced, it likely involves novel or multiple contraception-specific factors, potentially interacting with pre-existing medical risk factors and lifestyle behaviors. This still needs to be investigated.
 
Just as it took decades to find and validate genetic tests for drug metabolism in antidepressant or oncology drugs, similar timelines may support the development of genetic tests to guide contraceptive choice. That said, we can only hope that genetic testing technology becomes increasingly affordable, by the time of discovery, to lessen disparities in access globally.
 
✔️ Women’s lived experiences are variable, real, and biologically grounded, meaning they are not compliance or perception issues.

✔️ With larger cohorts and pooled datasets, pharmacogenomics may eventually stratify patients by likely efficacy or risk of side effects, progressing beyond today’s trial-and-error prescribing.
 
While this doesn’t reason a clinical guideline shift, this pioneering study lays critical groundwork for a future of precision contraception. Genetics does matter, most likely as part of a complex gene-environment network. Working alongside pioneers and experts, we are continuing this research so that our vision becomes a reality: a world where prescribing in women’s health is no longer trial-and-error, but done with true precision down to each individual’s biology and goals.

BMJ takes a stance on routine hormone panel testing.

In August 2025, The BMJ cautioned that routine hormone panel testing in menopause creates a “false sense of precision.”

The critique noted that the erratic hormonal fluctuations during perimenopause make one-off labs unreliable. Both ACOG and the Menopause Society advise that women over 45 with classic perimenopause symptoms should be diagnosed clinically rather than through blood, saliva, or urine tests. 

That said, hormone testing has appropriate uses in certain contexts. What’s striking, however, is how much commercial activity has emerged around testing, when not always necessary. Companies market blood, saliva, or urine panels as tools to “individualize” therapy for (peri)menopause. However, some critics argue that hormone panel tests mask a malpractice: the commercialization of women’s health, shifting evidence-based practice towards consumer-driven diagnostics that risk overtreatment and misinformation. This means that many clinicians and health professionals are encountering patients who arrive with test results or expectations shaped by non-standardized “optimal ranges.”

Some critics argue that hormone testing masks a malpractice: the commercialization of women’s health, shifting evidence-based practice towards consumer-driven diagnostics that risk overtreatment and misinformation. This means that many clinicians are encountering patients who arrive with test results or expectations shaped by non-standardized “optimal ranges.”

Compounded 'Bioidenticals'

Compounded bioidentical hormone therapies add another layer of complexity: while they have a role when commercial formulations aren’t suitable, risks such as inconsistent dosing or unopposed estrogen remain real. Meanwhile, terms like “natural,” “safer,” or “personalized” are frequently used in marketing but are not yet supported by robust evidence.

Ultimately, the issue is not whether testing or compounding can be useful - they can. The challenge is that marketing-driven diagnostics risk overtreating or misinforming patients, while distracting from what truly works: evidence-based, personalized, patient-centred care. That’s why we’re building solutions to help providers cut through the noise, streamline workflows, and focus on what matters most: shared decision-making and prescribing that is truly individualized.

Our focus.

At Dama Health, we are building a community of clinical leaders and innovators in precision medicine, women’s health, female longevity, and hormone health (like you!) to shape the future of evidence-based, patient-centered care. Together, we are working to:
 
✔️ Provide clinicians with contemporary decision tools to cut trial-and-error in HT and contraceptive prescribing.

✔️ Build infrastructure and integrations that adapt to every practice model, from boutique cash-pay clinics to large health systems.

 ✔️ Create trusted resources that close the education gap for both providers and patients.
 
That’s all from us this month! We’ll be back in a couple of weeks with more insights and updates. In the meantime, we’d love to hear: what topics in hormone health are top of mind for you right now?
 
Best,
The Dama Health Team

Authors: Dr Paulina Cecula, Namrata Ashok. Reviewed and edited by: Dr Aaron Lazorwitz, Elena Rueda