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 both measures her personal Follicle Stimulating Hormone (FSH) levels and combines them with her age and cycle history 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.¹

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.

The level of FSH typically correlates with the number of follicles she has left. As women age, they have fewer remaining follicles, therefore their body produces less Inhibin B, which is responsible for suppressing FSH levels.² 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 increases³, 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 they will only get their FSH results and not their 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 her convenience, the app will then remind her when to test on subsequent days; 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 is recorded in the app after testing.
• After all 5 tests are completed, the smart algorithm will indicate her most likely menopausal stage:
  Premenopause, Early perimenopause, Late perimenopause or Postmenopause.¹

Click here for full package instructions

* Compatible with most iPhones® and Android™ Phones.
For more information, check out: www.clearblue.com/connectivity-clearblue-mobile-apps

Easy to use FSH test stick

• Ergonomic: a long easy-grip handle with an ergonomically designed stick to help the user hold the device correctly in her urine stream
• 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 and their intensity can be logged and tracked
• Personalized report: easy-to-read report can be generated 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.

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 symptoms⁴).

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 generated, detailing her likely menopause stage and how it was determined, to share with her healthcare professional. It also shows up to 6 weeks of symptoms logged

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 criteria⁵
• Symptom tracking – symptom history can provide a foundation for discussions and potential next steps

Contraindications:

This product is not suitable for women who are pregnant, breastfeeding, are taking hormonal birth control, hormone replacement therapy, medications affecting FSH, have PCOS, or after surgical procedures which affect their cycle.

Not for contraceptive use.

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• Healthcare Professional Brochure
• Healthcare Professional Slide Deck