Is an at-home menopause test useful for women? Experts weigh in
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Key takeaways:
- A new at-home menopause test measures follicle-stimulating hormone (FSH) to predict menopause stage.
- The test combines serial FSH measurements with menstrual cycle and age data using a proprietary algorithm.
A new at-home menopause test hit the market last fall, promising women the ability to accurately measure a hormone associated with menopause stage and predict how close they might be to their final menstrual period.
The Clearblue Menopause Stage Indicator test promises to help women “understand their menopause journey” by tracking five serial follicle-stimulating hormone (FSH) measurements in urine samples, combined with personal menstrual cycle information and age in a free app. A “Smart Algorithm” in the app uses the test results and personal data to indicate a woman’s likely menopause stage: premenopause, early perimenopause, late perimenopause or postmenopause.
“Menopause itself is just a single day in time when a woman has gone 12 months from her last menstrual period,” Fiona Clancy, PhD, senior director of research and development at Clearblue, told Healio. “The period leading up to that time — typically 4 to 8 years — is when a women may begin to experience menopausal symptoms and cycle irregularity. But the reality is that most of those symptoms can overlap with symptoms women might attribute to something else, like stress or fatigue. It is during that time women most need support and validation that what they are experiencing is indeed perimenopause.”
The availability of an at-home menopause test sitting on big-box store shelves alongside pregnancy tests and ovulation predictors marks a change in the way menopause is being discussed and marketed — part of a larger trend the media has dubbed a “menopause gold rush.” In addition to tests, there is no shortage of related products currently marketed to menopausal women, from face creams, serums and supplements to branded “breathable” clothing designed to help with hot flashes.
The idea of an at-home menopause test has been met with both appreciation and skepticism. Some experts question the utility of testing to indicate what is a broad stage of life for women.
“Menopause is defined as no menstrual cycle for 1 year, and you don’t need a test for that,” Stephanie Faubion, MD, MBA, FACP, NCMP, IF, director of the Mayo Clinic Center for Women’s Health and the medical director of The Menopause Society, told Healio. “The availability of these types of tests speaks, again, to the fact that this is a group of women with unmet health needs. There are a lot of people trying to jump into the space and fill those needs with stuff that they think women may want. A lot of it is overkill. Just because we can test does not mean that we should or that it will be useful information.”
‘Holy grail’ of menopause research
The concept of a menopause test is not a new one. In a study published in 2020 in The Journal of Clinical Endocrinology & Metabolism, Nanette Santoro, MD, professor and the E. Stewart Taylor Chair of OB/GYN at the University of Colorado School of Medicine, and colleagues wrote that the ability to predict the final menstrual period accurately and precisely has long been a “holy grail” of menopause research. However, menstrual bleeding patterns, serum FSH levels or previous anti-Müllerian hormone (AMH) assays could predict the final menstrual period only within a window of 4 years, which is not clinically useful, they wrote.
In 2018, a two-site, enzyme-linked immunoassay measuring AMH (MenoCheck picoAMH ELISA, Ansh Labs) became the first FDA-cleared, clinically validated blood test to help physicians assess a woman’s menopausal stage. The blood test measures ultra-low levels of AMH to provide estimates of the time to final menstrual period, “facilitating better preventive care for symptoms that disrupt everyday quality of life,” according to the product website.
In the 2020 study, which assessed the accuracy of the test using serum samples from participants in the Study of Women’s Health Across the Nation (SWAN), Santoro and colleagues found that the amount of AMH in the blood can be used to estimate when a woman will undergo her final menstrual period and, in general, does so better than measuring FSH.
“When estrogen levels are low, FSH will go up, but it is not a direct measure of what is going on in the ovary,” Santoro told Healio. “AMH is a product of the very smallest, earliest growing follicles in the ovary. It is a much more direct measure of what is left in that ovary. If AHM declines for women who are not taking hormones or other things that are going to confuse us, it is highly predictive that menopause is happening.”
FSH is “a little less reliable because it is more variable,” Santoro said.
Clancy, who acknowledged that AMH is a marker of significant interest, said the Clearblue product was designed for ease-of-use and to align with specific menopause criteria.
“We developed this test for home use,” Clancy said. “Typically, AMH needs to be measured in blood. A urine test is simpler, and research shows urine and serum FSH agree very well. We wanted to use a hormone that is as well established as possible. We chose to measure FSH because we developed the product in line with STRAW+1-stages of reproductive aging criteria. AMH is included in those criteria; however, STRAW+10 states significant changes in AMH levels are not detected until late in the menopause transition.”
Santoro said an at-home test could potentially be useful for a select group of women with irregular menses.
“For women who cannot really tell from their menstrual period whether or not they are menopausal, or they are having symptoms where they are not sure if they are menopausal, a test can be helpful,” Santoro told Healio.
Assessing test accuracy
For an analysis presented in September at the Annual Meeting of The Menopause Society, Clancy and colleagues collected daily urines for up to 90 days from 108 women whose menopausal status was classified according to Stages of Reproductive Aging Workshop (STRAW+10) criteria and compared those data with quantitative urinary FSH concentrations for a second cohort of women using the Clearblue test. An FSH concentration of 25 IU/L or more was considered “positive.” All women also provided data on cycle length.
The researchers found that median urinary FSH levels increased across the menopause transition, from 6.4 IU/L for premenopause (n = 1,232), 10.6 IU/L for early perimenopause (n = 1,044), 32.8 IU/L for late perimenopause (n = 2,725) and 45 IU/L for postmenopause (n = 872).
Averaging across cycles, the percentage of “positive” tests increased as women moved through menopause stages, from 3.8% for women staged as premenopausal to 96.4% for women staged as postmenopausal.
Clancy said FSH alone differentiated premenopause from postmenopause; however, the addition of cycle length (< and 35days) to FSH concentration (< and 25 IU/L) differentiated peri- from pre- and postmenopause. Additionally, the percentage of positive FSH tests increased with longer cycle length as defined by STRAW+10 cohorts.
Clancy said the results demonstrate that the test accurately measures FSH, but she cautioned against drawing diagnostic conclusions from the test results before consulting with a health care provider.
“In terms of our FSH testing, we show it is over 99% accurate for FSH measurement,” Clancy said. “In terms of the product accuracy, that one is more challenging, because there is no gold standard. When we do a hormone measurement, we are able to compare it against a laboratory reference measurement and show how accurate we are. What we did was assess the product against the STRAW criteria and how accurately we align with that. It was 97.5% agreement vs. how it would correlate if we applied STRAW criteria directly. So, we do not quote an accuracy on the [stage] indication. We quote accuracy on the testing. [Test results are] not a diagnosis, and we are very clear about that.”
Facilitating conversations
Faubion cautioned that for women aged 35 years and older, FSH measurements can change by the day, making any home test tricky. Any women with questions about their menopause status or symptoms should talk to their health care provider, Faubion said.
“The bottom line is: If a woman feels she needs to pick up a test like this, she may be having some symptoms,” Faubion said. “If she is having symptoms, it does not matter if she is menopausal or perimenopausal; we are going to treat her symptoms. The FSH [measurement] does not matter.”
Santoro said products like menopause tests can be useful in specific circumstances. As the debate around the utility of such tests continues, Santoro said, the products speak to a need for more open conversations about menopause and menopause symptoms.
“Menopause is having a moment,” Santoro said. “I hope it lasts, because it is a fairly symptomatic period of life, and it is a good period of life for women to assess their health, understand what is happening and get treatment when they have the common menopausal symptoms. We have many great treatments and they are not all hormones. And hormones do not have to be fraught with all the dread and bad news that they have been weighed down with over the years. There are a number of arrows in the quiver that can be used to treat menopausal symptoms. Women should not suffer in silence.”
We want to hear from you
Healio wants to hear from you: What do you think are the pros and cons of at-home menopause testing? Share your thoughts with Healio by emailing the author at rschaffer@healio.com or posting to X (formerly Twitter) and tagging @HealioWomen. We will contact you if we wish to publish any part of your story.
References:
- Berga S, et al. Poster #14. Presented at: Annual Meeting of The Menopause Society; Sept. 27-30, 2023; Philadelphia (hybrid meeting).
- Finkelstein JS, et al. J Clin Endocrinol Metab. 2020;doi:10.1210/clinem/dgz283.
- MenoCheck. Available at: www.menocheck.com. Accessed Jan. 5, 2024.
- Sullivan K. Eight menopause products worth checking out. Everyday Health. Available at: https://www.everydayhealth.com/menopause/menopause-products-worth-checking-out/. Published Sept. 15, 2023. Accessed Jan. 5, 2024.
For more information:
Fiona Clancy, PhD, can be reached at fiona.clancy@spdspark.com.
Stephanie Faubion, MD, MBA, FACP, NCMP, IF, can be reached at faubion.stephanie@mayo.edu; X (Twitter): @StephFaubionMD.
Nanette Santoro, MD, can be reached at nanette.santoro@cuanschutz.edu.