Don't Waste Your Money on the Clearblue Menopause Journey Test

Here's what you really need to know about testing

Clearblue just rolled out the “Clearblue® Menopause Stage Indicator.” I think it’s worth discussing so you don’t end up wasting your money, but also because it’s a good chance to review some facts about testing so you can learn more.

Menopause Basics

If you have ovaries and a uterus, at some point, you will start menstruating, and at some point, you will stop menstruating and enter menopause. Menopause is the planned end of ovarian function when there are no more follicles capable of ovulation, estrogen produced by the ovary drops (other tissues still make small amounts), and progesterone production ends.

Menopause occurs when someone who is age 45 or older has gone one year without a period, and there is no other reason for this (for example, having a hormonal IUD or a thyroid disorder). The average age is 51-52, but the bell curve of “normal” is ages 45 to 55. Obviously, if you have your ovaries removed, that is a qualifying menopause event at any age.

Just like there are hormonal changes happening behind the scenes before the very first period, there are changes happening before the last. We call this time leading up to menopause the menopause transition. The average age of onset of the menopause transition is age 45, so obviously, 50% of people will have menstrual changes and other symptoms before age 45.

The first sign of the menopause transition is some irregularity in the cycle, meaning 8 days or more difference between the start of the next period (up to 7 days difference between day 1 of bleeding to day 1 is normal). This is called the early menopause transition. The late menopause transition is when cycles start to skip, and there will be 60 days or more between periods. This can sometimes come in fits and starts, meaning two or three typical cycles and then skipping one or two cycles. When this is happening, most people are 1-3 years from their final menstrual period or menopause.

When it comes to menopause, there is a great range in the timing of symptoms. Some people have bothersome symptoms during the menopause transition, and others do not. For some people, symptoms start around the final period or after, and for others, some of their symptoms can lessen once their periods stop. For this reason, I like to refer to the whole experience from the start of menopause transition onwards as the menopause experience. We can start hormone therapy or any therapy for hot flashes when they start; we’re not restricted by the menopause phase.

Premature menopause is when menstruation and ovarian function stop between ages 40 and 44, and primary ovarian insufficiency is when periods and ovarian function stop before 40 (we don’t call this premature menopause because about 10% of people can ovulate sporadically).

How We Determine When It’s Menopause.

In the world of evidence-based medicine, which is most definitely where you want to live,  we do not use blood tests or urine tests to diagnose menopause; we use age, menstrual status, and other symptoms. We make the diagnosis clinically (meaning without tests) for several reasons:

1) Hormone tests are not useful. Ovarian function does not wind down for everyone in a predictable pattern, and there is no single hormone value that says, “Yep, menopause.” We’re going to focus on FSH here, as that is the test used for Clearblue. FSH is a hormone released by the pituitary gland in the brain, and it stimulates follicles in the ovary to develop and produce estrogen. As you approach menopause, the follicles don’t respond as well. The brain compensates by increasing FSH (I like to think of the rising levels of FSH as raising your voice to motivate someone to get something done). However, the path to a high FSH varies. Look at this graph from SWAN (the Study of Women’s Health Across the Nation).

While before menopause, FSH rises for most people and will typically be > 25 IU/L one year before the final period, about 10% of people follow a trajectory where FSH stays low and doesn’t rise significantly until after the final period. 

2) Hormone Tests Can Be Unreliable. I don’t mean that the levels are inaccurate; what I mean is within any menopause hormone trajectory, there are individual ups and downs, meaning it’s not a smooth climb of FSH. Someone can have four months of no bleeding, have an FSH level that looks like menopause, and then boom, they ovulate. That is why we wait for one year of no bleeding. Testing just can’t account for the unpredictability of the last year or so of ovulation.   

3) Neither Hormone Levels nor Phase of Menopause Matters. We start therapy based on symptoms regardless of hormone levels, so whether you are one year before or one year after your final period doesn’t really matter. We only care about precision when it comes to the age of menopause for two reasons: to evaluate if bleeding is abnormal (meaning happening after menopause) and when contraception can be stopped. And even in these situations, we don’t use hormone levels.

How the “Clearblue® Menopause Stage Indicator” Works

The Clearblue urine test is supposed to test positive when the blood level of FSH is 25IU/L or higher. That data is combined with your symptoms and put together by an algorithm to tell you “Your menopause stage.” As they don’t list any peer-reviewed studies on their site that follow women for 5 or more years, I can’t tell you about the reliability of this approach. I also don’t know if Clearblue is any better than just asking someone about their period. And, of course, FSH levels don’t rise much for about 10% of people, so what about them? 

 The four stages of menopause used by Clearblue are shown here.

I suspect (although I don’t know for sure) they are using the staging criteria from the Study of Women’s Health Across the Nation (SWAN), which is:

• Premenopausal (no change in bleeding patterns)

• Early perimenopause (change in length of bleed or interbleed interval)

• Late perimenopause (no bleeding in 3-11 months)

• Menopause (no bleeding in 12 months)

As you can see, FSH levels don’t figure in at all.

While categories like these are important for a study like SWAN that is literally following people over time because they were capturing people as they moved into the menopause transition, they don’t help us much with medical care. Also, SWAN started in 1995, and terminology has changed. While it’s fine to use those terms in the confines of SWAN, we now use different terminology when speaking with patients and for research. Look at this chart from the 2011 Stages of Reproductive Aging Workshop (STRAW):

The term menopause transition is now favored for the time leading up to menopause. Perimenopause is technically the menopause transition plus the first year after the final period. Premenopause isn’t a formal category, although now most people use it interchangeably with the menopause transition, meaning the Clearblue test is using older terms for the phases of menopause, which will only add to the confusion. 

But category naming aside, we don’t do different tests or procedures or offer therapy based on being in the early or late menopause transition. It would be nice to be able to predict the date of your final period for all kinds of reasons, but for now, when your period starts spacing out by 60 days or more, menopause is likely 1-3 years away, and hormone tests don’t help us refine that any further.

After spending some time on the product’s website, something interesting caught my eye. Take a look at this screenshot.

Why do they have the number one as a reference after “likely menopause stage?”

Well, it turns out that refers to a footnote, in small print, that you must scroll all the way down the page to find. It says, “Only a healthcare professional can confirm your menopause stage.”

Wait a minute. This means for $29.99, the test isn’t valid enough on its own; you still need to talk with a healthcare professional.  

Le Sigh.

 What if You are Under the Age of 45?

If you are skipping periods, you may be in the menopause transition, but there could be another cause. The longer you go without a period, the more likely you are to be in early menopause or to be experiencing POI. If you are missing three or more periods in a row, then you should talk with your healthcare provider, and testing is almost certainly indicated. Not urine testing, though.

What if You Don’t Have Periods?

It’s true the stage of menopause and the determination of menopause is based on the pattern of menstruation, so what happens to those who don’t have a period? If you are 45 years or older, we will assume you are in the menopause transition/menopause if you are having any symptoms that match, for example, hot flashes, night sweats, or vaginal dryness.

If you are under age 45 and having symptoms that are consistent with menopause, then in this situation, we may suggest hormone testing…just like we would do if you are under 45 and have gone 90 days without a period. 

You can read more about this in a previous post, Hysterectomy and Menopause: How will I know?

What’s The Harm?

It’s a waste of money. We don’t start any therapy based on where you may or may not be on the menopause continuum. The menopause societies are all clear that testing isn’t required to start therapy. 

The Clearblue test could possibly cause confusion and even lead to difficult interactions with healthcare providers. It’s difficult to explain to someone that they spent their money on a test that doesn’t help. This can create a gap in care, where so-called alternative providers and people selling scammy supplements step in.  

You Don’t Need ClearBlue. Save Your Money.

References

1. El Khoudary SR, Greendale G, Crawford SL, Avis NE, Brooks MM, Thurston RC, Karvonen-Gutierrez C, Waetjen LE, Matthews K. The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN). Menopause. 2019 Oct;26(10):1213-1227. 

2. Tepper PG, Randolph JF Jr, McConnell DS, Crawford SL, El Khoudary SR, Joffe H, Gold EB, Zheng H, Bromberger JT, Sutton-Tyrrell K. Trajectory clustering of estradiol and follicle-stimulating hormone during the menopausal transition among women in the Study of Women's Health across the Nation (SWAN). J Clin Endocrinol Metab. 2012 Aug;97(8):2872-80. doi: 10.1210/jc.2012-1422. Epub 2012 Jun 1. 

3. Stuenkel CA, Gompel A. Primary Ovarian Insufficiency. N Engl J Med. 2023;388:154-63.

4. NAMS Position Statement. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause. 2022;29:767-794.

5. Cynthia A. Stuenkel et. al. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 11, 1 November 2015, Pages 3975–4011, https://doi.org/10.1210/jc.2015-2236