Rachel S. Rubin, MD
Medscape.com, Commetary, September 16, 2025
Some Background Information from the editor of PurenHealthInfo.com
When people are aging, male or female alike, his / her sex hormone levels is declining. This leads to depressive physiological changes, such as loss of muscle mass, energy, sexual features, and sadly, senile signs appear, in body shapes, in physical movement…. Because the understanding the correlation between sex hormones and aging, hormone replacement therapy for postmenopausal women and aging men was once an exhilarating discovery in the hope that a rejuvenating recipe has been found. They are noticeably testosterone, the male hormone for men, as well as estrogen, mostly in combination with progestin, the female sex hormones.
Some of the effects of steroid sex hormones are almost strikingly magical, such as athletes run faster, jump higher, swim speedier. Men regain their muscular appearance; ladies are able to retain their voluptuous figure, sleeping better, feeling stronger, not to mention men and women’s sex lives. However, reports of problems from hormone replacement ensue. After the report of the Women Health Initiatives in 2002, FDA placed the black boxes warning for hormone therapy both for men and women. Black box warning is a warning of high alert for medical providers, like “be careful! Are you sure you want to do this!?” Because of the warning, doctors have been reluctant to prescribe sex hormone medications for their patients, understandable they do not want the liability even for lady patients with conformed extremely low female hormone level. But, my observation is, that medical doctors have sex hormone medicines used for their wives, many female physicians at their postmenopausal age use female hormone therapy themselves. Affluent people with high education, either female or male are more intended using sex hormone medicines, you would ask “why?”. In recent years, further studies have been conducted, more investigated data are available, physicians and medical researchers, like this Dr. Rubin, have their voices rank out :“ this is wrong !”
The following is Dr. Rubin’s appeal to FDA to change the landscape of medical use of sex hormone for women. One fact need to be distinguished, in which, the side effects of systematic use of sex hormones could be more significant than those of local use, such as the vaginal estrogen cream that Dr. Rubin talks about.
—Website Editor.
Following is the transcript ( Link ) Dr. Rubin’s talk published in Medscape.com, this is an educational website for medical professionals:
Welcome back to another episode of Sex Matters. I’m Dr Rachel Rubin. I’m a urologist and sexual medicine specialist. Today I actually have an ask for you. I need your voices. I need your help.
I was very blessed because I was able to serve as part of an expert panel that went to the FDA with the commissioner himself, who asked us to give our opinions and our thoughts on hormone therapy and women’s health. I want you to watch our testimony. I want you to watch us talk about vaginal hormone therapy and how it can save lives.
Here’s the deal. Vaginal hormone therapy, estrogen, and dehydroepiandrosterone (DHEA) are safe for all humans. They prevent urinary tract infections, urinary frequency, urinary urgency, vaginal dryness, and pain with sex/arousal/orgasm. They are sexual health drugs that save lives by preventing urinary tract infections. There have even been publications, including some of our own, that show we could save Medicare billions of dollars a year if women were given safe and effective vaginal hormone therapy.
We’ve contributed to the development of clinical guidelines by the American Urological Association (AUA), which have been supported by the American Urogynecologic Society, the Menopause Society, and the Sexual Medicine Society of North America. These guidelines explain that vaginal hormones not only help with pain, dryness, and overactive bladder, but they can also prevent urinary tract infections. So for my primary care physicians, I need you to learn how to write these prescriptions. I need you to get confident and give it to everybody who has signs and symptoms of genitourinary syndrome of menopause. The prescriptions are easy to write and you have it within you to help your patients get relief. I talk about this at length on all of my channels and with all of my patients.
But the most important thing we can do now right now is to talk to the FDA about how we must remove the existing warning labels on these products. There is currently a black box warning on vaginal estrogen products that says these products cause stroke, heart attack, blood clots, probable dementia, and cancer.
Here’s the truth: If you know the literature — which I do, at length — none of it is true. In fact, you can’t find a single paper that shows any of this as happening with vaginal hormone therapy. In fact, the Women’s Health Initiative, the original study that led to the boxed warning in the first place, dedicated an entire part of their study evaluating the effect of vaginal estrogen, and they found no increased risk for stroke, blood clots, cardiovascular disease, or cancer.
We know that these medicines are safe. We even have data from a 2023 study of 50,000 breast cancer patients that demonstrates vaginal estrogen use is associated with a mortality benefit, not a decrease in mortality. Vaginal hormones are safe. They prevent urinary tract infections. They save lives.
A tube of estrogen cream can be as cheap as $13 a tube if you get it on CostPlus Drugs or $30 a tube with GoodRx. Plus, it’s often well covered by insurance. You can use 1 gram twice a week. Have your patients rub it into the vaginal tissue just like they rub moisturizer on their face. The estrogen cream will acidify their tissue, get their pH to 4.5, and prevent urinary tract infections as long as they use it — till death do they part. Vaginal inserts are also available, now. There are 10-µg vaginal estradiol inserts that go in the vagina twice a week; you can get an estradiol ring (Estring) that can go in for 3 months at a time; you could do vaginal DHEA in a nightly suppository form. All of this is laid out for you in full detail in the recent AUA guidelines on genitourinary syndrome of menopause.
I said it before and I’ll say it again: Vaginal estrogen is better than sildenafil (Viagra). Both vaginal estrogen and Viagra help with arousal, urinary symptoms, and sexual health. But vaginal estrogen is better because it also prevents urinary tract infections, and people die of urinary tract infections.
These vaginal estrogen products are safe to use if you’ve had a history of blood clots or if you’ve had a history of cancer. They are safe to use if you are on whole-body hormone therapy. And in fact, the AUA guideline statement #11 discusses how we should be adding vaginal estrogen to treat vaginal symptoms even among people on systemic hormone therapy.
If you have a patient with postmenopausal vaginal bleeding, send them to their gynecologist for a workup. But you don’t have to do routine surveillance of the endometrium here. And if you’re using these local products, you do not need to give progesterone. Now, if you’re doing whole-body hormone therapy and your patient has a uterus, then yes, estrogen and progesterone go together. But not with these local low-dose vaginal estrogen products.
No matter what specialty you are — primary care, cardiology, rheumatology, endocrinology — you can learn about this and you can write these prescriptions. So, with that in mind, I need you to tell the FDA that their labeling is incorrect and false. I need you to tell the FDA that you, as a doctor, need to have an easier way of getting your patients these medications.
Our patients see these warning labels and get scared. And this warning is a lie. It’s not correct. We must get updated labeling, and the head of the FDA knows this. He has asked for our help in getting this through the FDA. This is our chance to make change.
This push for changing the label on vaginal estrogen products is supported by gynecologists, urologists, oncologists and so many medical communities. Please go to this website before September 25 to have your voices heard. We need to have more than 500 comments advocating loudly for women’s health.
If you have any further questions, please feel free to reach out and please use the AUA guidelines for genitourinary syndrome of menopause. You will save lives, you will save money, and you will save so much of healthcare. Please get involved.
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