Gynecologists treat “genitourinary syndrome of menopause” with many modalities, but a common treatment is vaginal estrogen. Many women are concerned about the risks of estrogen, and there are very significant differences in the absorption of topical vaginal estrogen and systemic hormones, taken orally or topically as a patch or gel.
First, let’s define genitourinary syndrome of menopause. The lack of estrogen in the vaginal wall and vulvar tissues causes thinning of the tissue and decreased blood supply. The symptoms include vaginal dryness, burning, irritation, decreased lubrication, painful intercourse, and urinary symptoms of urgency, frequency, painful urination, incontinence and increased urinary tract infections. Quality of life can be adversely affected. The frequency of these symptoms is reported in 20-45% of postmenopausal women, but actually most women experience at least one of these symptoms.
Vaginal estrogen products are provided in creams, vaginal pills, and and a silicone ring that is left in place for three months. Although the serum level of estrogen rises when these products are first administered, the maintenance dose results in a serum estrogen level that remains in the postmenopausal range. The question is whether these products are related to in increase in blood clots, heart attacks, strokes, and breast cancer.
The significant symptoms of genitourinary syndrome and the need for long-term use of vaginal estrogen makes it critical that studies be done to demonstrate safety. A study in Menopause: The Journal of the American Menopause Society, published in January, 2018, analyzed data from the Women’s Health Initiative. The use of vaginal estrogen was evaluated through self-assessment questionnaires, but type of vaginal estrogen was not stratified. The average age of patients in the study was 65 years, and mean follow-up was 6-7 years, with an average time using the products was about 40%.
The study results demonstrated that postmenopausal women who took vaginal estrogen had similar risks of breast cancer, stroke, colon cancer, endometrial cancer, blood clots and pulmonary emboli as those who had not used vaginal estrogen. The study actually demonstrated decreased risks of hip fracture and coronary artery disease.
Breast cancer patients on aromatase inhibitors will exhibit an increased serum estrogen level than the reduced level of estrogen derived from use of these medications, and probably should not use vaginal estrogen products. Women who have or have had breast cancer may be able to use vaginal estrogen if approved by their oncologist on a case by case basis.
If you read the package insert of vaginal estrogen products, the labeling is the same as higher dose systemic products. The American Menopause Society is advocating for a change in the labeling because this study and almost every other observational study done thus far do not demonstrate an increased risk for vaginal estrogen users. Currently the FDA is considering a proposal to change the warning label. Stay tuned!
Marilyn C. Jerome, MD
Foxhall OB-Gyn Associates
Menopause: The Journal of the American Menopause Society, Volume 25, Number 1, January 2018. Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women’s Health Initiative Observational Study. Carolyn Crandall, MD, et al.