From GSM guidance to HRT reform: A landmark year for women’s health

This year has placed a long-overdue spotlight on women’s health.

While many urologists and sexual medicine specialists have been tireless champions of women’s health needs, it is only recently that these issues have started to gain substantial traction within national guidelines and federal policy. The lack of recognition can be in part attributed to outdated data and subsequent stigma that have pushed women’s health to the sidelines.

“While men have medication that's very well covered for erectile dysfunction, women have fewer options, not because there's not medication. We do have medications, but coverage is lacking, and access is lacking,” explained Rachel Pope, MD, MPH, an obstetrician/gynecologist in the department of urology at University Hospitals Cleveland Medical Center in Cleveland, Ohio.

In 2025, these issues began to take center stage. Notably, we saw 2 pivotal advancements in this space: the development of the first-ever guideline on genitourinary syndrome of menopause (GSM) as well as the removal of the black box warning label on hormone replacement therapy (HRT) for menopause.

GSM guideline offers evidence-based guidance for the first time

In April 2025, at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada, the AUA released their first-ever guideline on GSM. This milestone both recognized GSM as a priority in urologic care and equipped urologists with the tools to manage it, thus enhancing care for women across the country.

The term GSM was introduced in 2014, and according to the AUA, “describes the spectrum of symptoms and physical changes resulting from declining estrogen and androgen concentrations in the genitourinary tract during perimenopause and after menopause.”1 This condition affects millions of postmenopausal women, impacting urinary, sexual, and vaginal health, yet it has remained historically under-addressed in urology.

Until the release of the GSM guideline in 2025, there had been no consensus regarding the number or type of symptoms needed to diagnose GSM nor a requirement for identifying concurrent physical signs. Thus, the guideline statements—26 in total—offer evidence-based guidance on care for these patients for the first time.

“It will truly save lives,” said Rachel Rubin, MD, in an episode of Pearls & Perspectives at the AUA Annual Meeting. “There's a paper at this meeting that looks at the reduction in sepsis, mortality, [and] hospitalizations in the patients who took vaginal estrogen. This document gives permission to clinicians of every specialty, to say, ‘This is not just a little vaginal dryness that's uncomfortable. This is sepsis, death, decrease in sexual health, urinary overactivity, urinary tract infections.’ This is urology. By giving women vaginal hormones, not just estrogen, we will save lives.”

Updated warning labels on HRT overturn misguided data

Women’s health became a topic of conversation again in November 2025 when the FDA convened an expert panel to discuss the labeling on HRT for menopause.

During the discussion, the experts outlined what they called outdated data surrounding HRT, namely from the Women’s Health Initiative (WHI) study, which found a statistically nonsignificant increase in the risk of breast cancer among patients receiving estrogen plus progestin. These data led to the inclusion of a black box warning label on all estrogen-containing products—a move which many physicians argued was too broad.

Since the findings were released in 2002, advocates for HRT have emphasized the differences between the context of the WHI study and the use of HRT in routine practice. Particularly, the study used conjugated equine estrogens, which is a hormone formulation that is not commonly used in clinical practice today.2 Clinicians have argued that risks associated with this formulation cannot be generalized to all forms of hormonal therapies, noting a clear difference between systemic products and local vaginal estrogen. Further, the average age of participants in the WHI study was 63 years, which is over a decade past the average age of women experiencing menopause.

Ignoring these nuances has led to decades of fear and misinformation surrounding HRT. The warning label both discouraged physicians from prescribing vaginal estrogen and prevented women from adhering to life-changing care.

There have been a multitude of studies that have confirmed the safety and efficacy of local vaginal estrogen. Specifically, data have shown that women who initiate HRT within 10 years of the onset of menopause have reduced all-cause mortality, as well as a 50% reduction in the risk of cardiovascular disease,3 a 35% reduction in the risk of Alzheimer’s disease,4 and a 50% to 60% reduction in the risk of bone fractures.5

Based on these data and expert advocacy, in November 2025, the FDA issued a correction to their decision 2 decades prior, announcing plans to remove the broad box warning labels on HRT for women experiencing menopause.2 This decision was met with excitement by experts across urology and sexual medicine, who emphasized that these changes would allow for the destigmatization of HRT and equip physicians with confidence in prescribing it.

“This is a huge step forward for women’s health,” said Ramzy T. Burns, MD, an assistant professor of urology and adjunct assistant professor of obstetrics and gynecology at Indiana University School of Medicine. “It finally reflects what the evidence has shown for years and allows us to have more open, accurate conversations about hormone therapy with our patients.”

Many experts also reflected on the significance of recognizing women’s health on a national scale, albeit following a misguided recommendation.

Pope noted, “While I do think the changes are hugely overdue and some of these things could have been prevented, I'm so glad that the whole nation has now moved attention towards women's health.”

FDA decisions move the needle toward individualized care

The decision to remove the warning labels on HRT for menopause not only affirms the safety and efficacy of this therapy for women, but also allows clinicians to provide care on an individual basis. Rather than having a blanket warning for everyone, physicians can have a discussion with patients to determine who might be best suited for this treatment option.

“My counseling is now going to shift from a place of fear to a place of clarity,” said Sameena A. Rahman, MD, a clinical assistant professor at Northwestern Feinberg School of Medicine in Chicago, Illinois. “Instead of starting out the discussion with, ‘I know that you’ve heard about the fear around using hormones,’ now I’m going to start with, ‘Is this the right option for you?’”

For many, the hope is that these changes not only impact the current delivery of care but also the way that future generations of urologists are trained on GSM and vaginal estrogen. In the current system, education surrounding women’s health needs is lacking.

“One of the things that I presented at The Menopause Society this past year was a survey I did on 150 [physician assistants] PAs, asking them what their menopause training looked like in their PA programs,” said Aleece Fosnight, MSPAS, PA-C, CSC-S, CSE, IF, MSCP, HAES, founder of the Fosnight Center for Sexual Health and a medical advisor for Aeroflow Urology. “Only 3% of them said that they felt like they had adequate training in menopause in their programs.6 That's awful. We need to do better, and that needs to start at the education level. I'm hopeful that the media surrounding this box warning [update] will open up the eyes of our medical schools, our PA programs, and our nursing programs to say this is something that we need to implement sooner than later.”

Recent women’s health wins reflect the power of advocacy

It’s important to emphasize that these changes did not happen overnight. Both the GSM guideline and the label update for HRT are the result of years of advocacy from urologists and sexual medicine specialists across the country. It is the product of many physicians who looked at the current state of care for women and said, “This system is not working, and our patients deserve better.”

“This has been over a decade in the making,” Rahman added. “I think this proves the power of advocacy. A lot of people say they don't want to get political, they don't want to get involved. But look, this push happened because people got involved, because people said, ‘You know what? We are speaking for the voiceless.’ As clinicians, we have authority in this area, we have knowledge, we have science, and we have research that promotes this. We need to get out there and just get loud about it, because change can happen.”

REFERENCES

1. American Urological Association Releases New Guideline on Genitourinary Syndrome of Menopause. News release. American Urological Association. April 28, 2025. Accessed December 22, 2025. https://www.auanet.org/about-us/media-center/press-center/american-urological-association-releases-new-guideline-on-genitourinary-syndrome-of-menopause

2. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. News release. US Food & Drug Administration. November 10, 2025. Accessed December 22, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

3. Connor EB, Bush TL. Estrogen and coronary heart disease in women. JAMA. 1991 Apr 10;265(14):1861-7

4. Paganini-Hill A, Henderson VW. Estrogen replacement therapy and risk of Alzheimer disease. Arch Intern Med. 1996 Oct 28;156(19):2213-7

5. Weiss NS, Ure CL, Ballard JH, Williams AR, Daling JR. Decreased Risk of Fractures of the Hip and Lower Forearm with Postmenopausal Use of Estrogen. N Engl J Med. 1980 Nov 20;303(21):1195-8. doi:10.1056/NEJM198011203032102

6. Fosnight A. The Alarming Unmet Educational Needs in Menopause Care for Physician Associates: Revealing the Systemic Gaps in PA Training and the Urgent Call to Integrate Menopause into Clinical Education. Presented at: The Menopause Society’s 2025 Annual Meeting. Orlando, Florida. October 21-25, 2025. Poster 53. https://tms.scientificposters.com/epsAbstractTMS.cfm?id=1