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· Before you start, review the contents of the kit first and read the instructions carefully.
· Estroven Menopause Monitor test cassettes - 2 individually wrapped pouches
· Plastic droppers - 2 per kit.
· Urine Collection Dish – 2 per kit
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FIG. 1: Foil Pouch Containing Test Cassette |
FIG. 2: Dropper |
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FIG. 3: Test Cassette |
FIG. 4: Plastic DISH |
MATERIALS REQUIRED
· Timer
· Store test kit at room temperature (15 – 28°C; 60 – 82°F)
· Do not use the test cassette after the date printed on the foil pouch
· Do not allow the cassette to freeze
· Keep away from moisture, heat, or direct sunlight
The term “Menopause” is a long complex series of changes beginning with symptoms such as irregular menstrual cycles, hot flashes, mood swings, etc., associated with early menopause (called perimenopause) through the stopping of menstrual periods for a full twelve months (menopause). Menopause sometimes called “change of life” that happens to all women commonly occurs between the ages of 40 to 55 but can occur as early as 35 or as late as 60. During the stages of perimenopause, changes take place in the balance of hormones that regulate and control your monthly menstrual cycle. This slow “change” in ovary function can happen between 2 and 10 years before the final period. As a woman grows older and passes out of childbearing stage of life, her ovaries gradually make less of the hormone estrogen and another hormone; FSH (follicle stimulating hormone) increases. FSH normally regulates the growth and development of an egg. The brain directs the body to increase production of FSH so an egg can mature. Once this part of the monthly cycle is complete, FSH production is stopped and it returns to normal. As the body decreases estrogen with age, more FSH is made. Over time these hormone changes cause your menstrual periods to stop completely. This permanent stopping of menstrual periods for 12 months is called Menopause. Until the final menopause 12 months of no periods, a woman can still get pregnant even though the chances are diminished.
The symptoms of perimenopause may be hot flashes, irregular menstrual cycles, heavier or lighter bleeding during periods, interrupted sleep, mood swings and depression, short-term memory loss, unexplained fatigue, and vaginal dryness. Although menopause is a natural part of growing older, many women find their symptoms can interfere with their daily lives. These symptoms can be managed in consultation with your doctor. If you are concerned about the symptoms of menopause talk to your doctor about treatment.
Without hormone therapy with the long–term affects of menopause are known to cause the loss of bone calcium resulting in osteoporosis (brittle bones), changes blood pressure and blood vessel walls with increased risk of heart disease starting approximately 10–15 years after menopause has begun. Other affects such as emotional loss of well being, depression, incontinence and reduced sex drive can occur.
1. The test is intended for HOME USE.
2. Read instructions carefully and understand how to use this test before you begin.
3. The test is for FSH use only and is not a pregnancy or ovulation test.
4. Please keep kit and its parts away from children.
5. Make sure that the Menopause Monitor cassette is at room temperature before use.
a. The first morning urine contains the highest level of FSH and is the best for testing. Urine collected during the day will contain lower FSH levels and may cause a false negative result. Do not drink fluids after midnight before testing in the morning.
a. Catch the urine mid-stream into the clean dry collection dish in the kit. Discard after use.
b. If you prefer to test your urine later, the urine must be stored refrigerated at 2-8oC for up to 24 hours only. Note: In this case bring the urine sample to room temperature before testing.
PROCEDURE
1. Remove the test cassette from the foil wrapper by tearing at slot on the side of bag. [It is not necessary to remove the desiccant pack.]
2. Place the cassette on a hard flat surface with the window facing up.
3. Fill one dropper from the kit with urine from the dish. Hold the dropper vertically (See figure 5) and gently squeeze 4 full drops of urine in the round window on the cassette. Discard the dropper after use into a waste container.
Note: This test is designed to give proper results with 4 drops of urine. Adding less than the 4 drops may not be enough liquid to flow through the (C) mark and will give a partial faint line or no line. If the line is not clearly visible, not enough liquid was added and the test should be repeated with another cassette.
FIG. 5: dropping urine into the Menopause Monitor
4. Set a timer for 15 minutes and let the liquid flow undisturbed. Do NOT move the cassette during this time.
5. At the end of the 15 minutes, read the line(s) in the window of the cassette. Do not move the device until you have checked the line(s).
RESULTS
1. Negative: One pink/purple colored band appears in the rectangular window near the (C) mark. No colored band near the (T) mark means the FSH level is negative.
2. Positive: In addition to the pink/purple line by the (C) mark, a second pink/purple colored line also appears near the (T) mark means the FSH level is positive. Re-test in 1 – 2 weeks using the second test cassette.
Please Note: ANY PINK/PURPLE line that appears near the (T) mark of the cassette within the 15-minute time is considered a positive result.
1. Invalid: A pink/purple line should always appear near the (C) mark. If there is no pink/purple line visible near the mark, the test is invalid. In that case it is recommended that the test should be repeated with a new kit or call 1-888-445-4447.
INTERPRETATION – In Women Having:
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1st Test |
2nd Test |
INTERPRETATION |
Irregular Cycles plus menopausal symptoms |
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Positive |
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May be perimenopausal, but should repeat the test and consult physician. Contraception should not be discontinued. |
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Positive |
May be experiencing perimenopause, consult physician to discuss results and other causes of symptoms. Contraception should not be discontinued. Therapy options should be discussed. |
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Negative |
Appears to not be perimenopausal this cycle. If symptoms such as hot flashes or excess irritability persist, repeat the test in 1 – 2 weeks. Discuss test results and symptoms with physician. Seek medical advice about other causes of irregular cycles. |
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Negative |
Appears to not to be perimenopausal. However, if symptoms persist, perimenopause may still be considered, but other causes of irregular cycles should be sought. Discuss test results and symptoms with physician |
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Positive |
Negative |
May be experiencing perimenopause, consult physician. Contraception should not be discontinued. You may still be making eggs since one of the tests may have been done at the time of release of your egg or you may be in the early onset of perimenopause. |
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Negative |
Positive |
May be experiencing perimenopause, consult physician. Contraception should not be discontinued. |
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Experiencing symptoms, but no menstrual period for 12 months |
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Positive |
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Appears that menopause has occurred. Maybe repeat test, but definitely consult physician since there could be other reasons for lack of menstrual periods, i.e. age, weight, presence of tumours, etc. Therapy options should be discussed. |
NOTE: The results of this test should be discussed with a physician for help in interpreting the results and managing the symptoms.
1. Only first morning urine should be obtained and tested. Drinking fluids after midnight should be avoided to reduce dilution of urine. If a negative result is obtained, and you know you drank large amounts of fluids the night before or drank after midnight, repeat the test.
2. Each test cassette should be used only once. Discard after use.
3. This test must not be used to determine fertility. It cannot be used to determine your ability to become pregnant. Do Not make contraception decisions based on the results of this test. Please discuss your contraceptive needs with your doctor.
4. Oral contraceptives may affect the test and produce inaccurate results.
5. Hormone replacement therapy and estrogen supplements may affect the test and produce inaccurate results.
6. Follow the directions exactly.
7. If the test kit is expired, do not use the test cassette(s).
Questions and Answers:
What is Menopause?
The term “Menopause” is a long complex series of changes beginning with symptoms such as irregular menstrual cycles, hot flashes, mood swings, etc., associated with early menopause (called perimenopause) through the stopping of menstrual periods for a full twelve months (menopause). Menopause sometimes called “change of life” that happens to all women commonly occurs between the ages of 40 to 55 but can occur as early as 35 or as late as 60. Menopause occurs when a woman has not had her menstrual period for a full 12 months. Negative FSH tests can occur anytime during these ages.
Once a woman has gone through menopause, her ovaries no longer release eggs each month, and she cannot become pregnant. However, changes in the balance of hormones that control the menstrual cycle begin several years before menopause. The changing hormone levels can cause a variety of symptoms associated with the stages of menopause.
I have some symptoms but I still get my period. Am I in menopause?
You are not in menopause, but you may be experiencing perimenopause- the medical term for the months or years leading up to menopause. Many women experience some of the symptoms associated with perimenopause even though they still menstruate. Although the hormone balance in their bodies is changing, their ovaries continue to release eggs. This means that pregnancy may still be possible.
What is Perimenopause?
Perimenopause occurs when there are changes in the levels of the hormones that regulate a woman’s menstrual cycle. It is the time when periods become irregular or missed. Physical and emotional conditions such as hot flashes, interrupted sleep, mood swings and depression, short-term memory loss, unexplained fatigue, and vaginal dryness can happen.
What is FSH?
FSH is short for Follicle Stimulating Hormone. FSH is produced by the pituitary gland at the base (bottom) of the brain. FSH is always present in the body, but the pituitary produces more of this hormone when the ovaries slow down the production of eggs.
Why Test for FSH?
Positive levels of FSH can help a woman identify that her period changes are caused by “menopause”.
Will my periods tell me if my ovaries are slowing down or stopped?
The answer is No. Some women can still be producing eggs and having their periods while their FSH levels are rising.
If the Test is positive, can I still get pregnant?
If both tests are positive, it means your body is producing high levels of FSH and you may be in menopause. See your doctor to talk about your test results and to learn more about menopause and your future health.
If the first test is negative, your FSH level is not elevated, and you are probably not in menopause. Consider repeating the test again. If you have concerns about menopause or your menstrual cycle, talk to your doctor about your test results.
Mixed test results means the FSH level in your body is not consistently high. Because your FSH levels are changing, you may be in perimenopause. Consider repeating the test in 6 to 12 months. If you have concerns about menopause or your menstrual cycle, talk to your doctor about your test results.
If both tests are positive, does that mean I can’t get pregnant?
Do not use your test results to make decisions about birth control (contraception). The ESTROVEN MENOPAUSE MONITOR does not test for your ability to become pregnant. Two positive test results simply mean that your FSH levels are consistently high. Not having a menstrual period for one full year is the only way to be sure you have gone through menopause and can no longer become pregnant.
The Estroven Menopause Monitor was compared to laboratory test using blood to detect FSH levels and showed a 99% agreement to this test. This test detects positive or negative FSH while laboratory tests will provide specific levels of the hormone that are useful for physicians in identifying proper therapy.
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