Clearblue® Menopause Stage Indicator

Personalized results based on FSH levels, age and cycle history

The Clearblue® Menopause Stage Indicator is the only at-home test that combines both her age and cycle history with her personal Follicle Stimulating Hormone (FSH) levels in an easy-to-use app.

This product is designed to indicate the user’s likely menopausal stage: Premenopause, Early Perimenopause, Late Perimenopause or Postmenopause, based on the information and test results provided.*

FSH levels and Reproductive Aging

While it’s not unusual for FSH levels to vary across the menstrual cycle, a regularly elevated level of FSH can be an indication that a woman is approaching menopause, or in postmenopause.1,2,3

The level of FSH typically correlates with the number of follicles remaining in a woman’s ovaries.4 As women age, they have fewer remaining follicles, therefore their body produces less Inhibin B, which is responsible for suppressing FSH levels.5 This means that the pituitary gland continues to produce increasing amounts of FSH, as the body attempts to mature the remaining follicles. As the number of follicles drops, the level of FSH increases5, making FSH a useful tool for determining a woman’s likely menopause stage.

By taking multiple FSH tests, on alternative days, normal cyclic fluctuations in FSH can be accounted for and a more accurate indication of her FSH levels can be determined, compared to a single one off measurement.

It is for this reason the Clearblue® Menopause Stage Indicator utilizes her personal FSH levels, in combination with her age and cycle history, to indicate her likely menopause stage.

How Clearblue® Menopause Stage Indicator works

  • The user must download the free-to-download app** to their mobile device before testing, otherwise she will only get their FSH results and not her likely menopausal stage
  • After downloading the app from meno.clearblue.com/app (or search the App Store or Google Play store), she simply creates an account as directed

  • She can start testing at any time, though should always use the first urine of the day; with the option for the app to provide her a reminder to test; results can only be recorded until midnight on the day of testing
  • The test should be done with the first urine of the day and can be used by either holding the test stick in the urine stream for 5 seconds, or dipping it in a collected urine sample for 20 seconds
  • Results from the FSH test sticks must be read within 8 minutes of testing.
    Two lines indicate a positive result, no matter how faint or dark the lines are.
    One line indicates a negative result.
    A control line must always be seen in the control window to indicate the test has worked.

  • The FSH test result should be recorded in the app after testing.
  • After all 5 tests are completed, the smart algorithm will indicate her likely menopausal stage:
    Premenopause, Early perimenopause, Late perimenopause or Postmenopause.*

Click here for full package instructions

Example of menopause stage results

Easy to use FSH test stick

  • Ergonomic: a long curved, long easy-grip handle
  • Easy to use: a wide 18 mm tip to help her sample and unique Floodguard™ Technology to make it easy to test correctly
  • Easy to read: a large easy-to-read result window
  • Accurate: >99% accurate when tested with positive FSH (≥25mIU/mL FSH) and negative FSH urine samples in laboratory testing

Free-to-download app** which utilizes a smart algorithm

  • Smart algorithm: combines her cycle information, FSH results, and age to indicate her likely menopause stage
  • Simple to use: in-app step-by-step instructions
  • Easy testing routine: a countdown timer indicates when to read the test result
  • Tracking: cycle history, period flow and 19 symptoms with their intensity can be logged and tracked
  • Personalized report: easy-to-read report can be simply downloaded or emailed and shared with her healthcare professional
  • Educational content: information on her likely stage and articles reviewed by scientists, experts and healthcare professionals. We are always interested in new input, please reach out to us if you would like to contribute.

Example symptom tracking on the app

Menopause stages

Premenopause

  • Premenopausal women experience periods and are still considered fertile or in the reproductive phase of life.

Early Perimenopause

  • A variable follicular phase is due to changing levels of FSH. The woman experiences menopause symptoms, but her period has not stopped yet or it has been less than a year since the last period.

Late Perimenopause

  • Menstrual cycles become more irregular in length and hormonal levels go through extreme changes. There is a space of >60 days between each period. Women have more cycles in which an egg is not released at all (anovulation) and FSH levels are elevated at this stage. There is an increased likelihood of vasomotor symptoms during this stage (50–82% of women in the USA experience vasomotor symptoms6).

Postmenopause

  • After menopause, the next stage is postmenopause. Women may still experience some of the perimenopause symptoms, but often these will improve and resolve with time.

Advantages of the Clearblue® Menopause Stage Indicator

This product is not intended to replace the care provided by healthcare professionals, but rather to provide women with a tool to educate, engage, and empower them on their menopause journey. The information she gains from Clearblue® Menopause Stage Indicator can be used to facilitate a more positive and effective conversation between a woman and her healthcare professional.

  • Smart algorithm in line with clinical criteria for assessment of reproductive aging
  • Uses five FSH tests on alternate days to account for any potential mid-cycle FSH elevation, allowing her to test at any time in her cycle
  • Personalized results based on the user’s FSH levels, age, and cycle data
  • Simple testing routine
  • Allows comfortable at-home testing using urine
  • Enables tracking of symptoms and their intensity
  • A personalized summary report can be downloaded, detailing her likely menopause stage* and how it was determined, to share with her healthcare professional. She can choose to include a 10-day snapshot of symptoms logged with intensity or a 6-week detailed view including frequency of symptoms.

Benefits of this product for HCPs:

  • Empowers patients with a personalized report – allowing for more productive discussions during time restricted consultations
  • Accountability – creating engagement and allowing women to take control of their menopause journey
  • Scientifically supported - classification of likely menopause stage in line with the Stages of Reproductive Aging Workshop (STRAW+10) classification criteria1
  • Symptom tracking – symptom history can provide a foundation for discussions and potential next steps

Contraindications:

Clearblue® Menopause stage Indicator is designed to help her understand her menopause journey. It takes into account menstrual cycle information, age and her natural FSH levels to indicate her likely menopause stage*, therefore it is NOT suitable for all women. This product is not suitable for women who are:

  • Pregnant
  • Breastfeeding
  • Taking hormonal birth control (oral contraceptives, hormonal IUD such as Mirena, implant, injections, etc)
  • Using hormone replacement therapy (estrogen/progesterone pills, estrogen/progesterone patches, estrogen gel, etc)
  • Using medications affecting or containing FSH
  • Have PCOS
  • Have had any surgical procedure which affect their cycle (hysterectomy, bilateral oophorectomy, endometrial ablation, etc

The test should NOT be affected by common painkillers, alcohol or antibiotics.

Not for contraceptive use.

Download

*A confirmed menopause stage diagnosis can only be made by a Healthcare professional after all clinical and laboratory findings have been evaluated.

**Compatible with most iPhones® and Android™ Phones. To find out if your phone is compatible and if the app is available in the country you live in, check out https://www.clearblue.com/connectivity-clearblue-mobile-apps

  1. Harlow SD, Gass M, Hall JE, et al. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause. 2012;19(4):387-95. doi: 10.1097/gme.0b013e31824d8f40.
  2. Santoro N, et al. Body size and ethnicity are associated with menstrual cycle alterations in women in the early menopausal transition: The Study of Women’s Health across the Nation (SWAN) Daily Hormone Study. J Clin Endocrinol Metab. (2004) 89: 2622–2631.
  3. Shin SY, et al. Analysis of serum levels of anti-Mullerian hormone, inhibin B, insulin-like growth factor-I, insulin-like growth factor binding protein-3, and follicle-stimulating hormone with respect to age and menopausal status. J Korean Med Sci. (2008) 23: 104–110.
  4. Steiner AZ, et al. Urinary follicle-stimulating hormone as a measure of natural fertility in a community cohort. Reprod Sci. (2013) 20: 549–556.
  5. Roudebush WE, Kivens WJ, and Mattke JM. Biomarkers of ovarian reserve. Biomark Insights. (2008) 3: 259–268.
  6.  ACOG Practice Bulletin No. 141: management of menopausal symptoms. (2014). Obstetrics and gynecology, 123(1), 202–216. https://doi.org/10.1097/01.AOG.0000441353.20693.78.

Always read full instruction leaflet of product before use. This material is intended for healthcare professionals only. It is for general information only with no warranties, representations or undertakings, express or implied, and does not constitute medical advice. It may refer to products not yet registered or approved in a given country. Please ask your local pharmacist or SPD contact for products available in your country. Product images are for illustration only. Clearblue® is a trademark of SPD Swiss Precision Diagnostics GmbH (“SPD”). © 2024 SPD (except for any third party content identified as such). All rights reserved.