An at-home menopause test kit from Clearblue, the maker of pregnancy tests, is now on store shelves across the United States. The company says the test, which became available in August, helps women determine which stage they’re in during the lead-up to menopause. Last week at a meeting of the nonprofit Menopause Society, the company presented data from a study it funded, suggesting that the test can pick up on hormone levels and other indicators associated with the life phase.
The yearslong transition to menopause is often “shrouded in mystery,” said Clearblue’s head of scientific and medical affairs, Lucy Broadbent, and the test is meant to clear some of that confusion.
Despite the study findings, some experts are skeptical that an at-home test will be accurate, particularly for women in perimenopause, when “hormones are all over the map,” said Dr. Ekta Kapoor, assistant director of the Mayo Clinic Center for Women’s Health. A snapshot of hormone levels at one point might look very different from one just a few weeks later, making it difficult to make sense of test results.
Still, the kit may end up being used much like a fitness tracker — simply providing women with additional data points, said Dr. Nanette Santoro, a professor of obstetrics and gynecology at University of Colorado School of Medicine. This might be especially helpful in the early stages of menopause when “women really don’t get much validation” by doctors, she added, offering some assurance that they’re not just imagining the changes they’re experiencing.
How does it work?
The test, which costs between $20 and $30 and looks similar to a typical home pregnancy test, requires five urine samples over 10 days. It is designed to detect high levels of follicular stimulating hormone, which are associated with the transition to menopause. During regular menstruation, F.S.H. rises in the run-up to ovulation every month, helping to spur a follicle to release an egg, and then declines, Dr. Kapoor said. As menopause approaches, the peaks and dips of F.S.H. become more irregular, she said.
The test, Ms. Broadbent said, is based on a widely used tool to assess the transition to menopause, known as the Stages of Reproductive Aging Workshop, which considers F.S.H. levels among a number of other factors.
Other available F.S.H. tests, which are often marketed for fertility tracking but can also be used to detect signs of menopause, measure levels once at the beginning of the menstrual cycle. Clearblue said that because its test spans 10 days, women could use the kit at any point in their cycle; however, it is not suitable for those who are on hormonal birth control or have polycystic ovarian syndrome.
Users of the test are prompted to enter the results of each sample (positive or negative) into a Clearblue app, which also tracks symptoms. The app uses F.S.H. levels, age and period cycle history and length to determine what stage of the menopause transition a user might be in — from perimenopause, the early stages of the transition, to postmenopause, after a woman has had no periods for a full year.
In the Clearblue-funded study, 108 women aged 45 to 60 took the five-test regimen during multiple menstrual cycles. Researchers found that the further along in the menopause process they were, the more likely they were to get more than one positive test out of the five.
Is it useful?
“The most useful way to tell, epidemiologically, how close you are to menopause is really looking at menstrual cycle history,” Dr. Santoro said. “When a woman is over 47 and she’s gone more than 60 days without a period and she was regular before,” it is highly likely that she will be done with menopause within a few years.
In Dr. Kapoor’s clinic, when patients ask for blood work and F.S.H. tests, “I am more often talking them out of it than recommending it,” she said, because if a woman’s cycle history suggests she might be menopausal, no matter what the F.S.H. results say, symptom management options, such as hormone therapy, don’t change.
Some experts said that there might be some cases in which the test results could provide both patients and doctors with helpful information, such as for women who begin menopause prematurely, said Dr. Mary Dolan, a professor of obstetrics and gynecology at Emory University School of Medicine. Women who have had a hysterectomy with their ovaries intact and no longer have periods to track irregularities might also benefit from knowing their F.S.H. levels, she added.
The test is “not at all intended to replace the care that she would have with her doctor,” Ms. Broadbent said.
“Our advice is that you need to go speak to your health care provider to confirm menopause or to discuss next steps,” she added. The app creates a PDF with the results and a symptom summary that users can share with their doctors.
Dr. Dolan, who has for years seen women struggle to get the menopause care they need, said there’s a clear benefit to giving “a woman more empowerment over her health.”