Dr. Richard Cohen's OptiMale Hormone/Testosterone Test Kit

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OptiMale Hormone/Testosterone Test Kit: Check Your Testosterone Levels!

Did you know?
Low testosterone and DHT levels can greatly effect energy, mood, physical strength and sexual function.

Modern lifestyle along with chemical pollution can cause elevated levels of male estrogen which can reduce libido, increase body fat and enhance your risk of
cardiovascular disease and prostate disease.

The proper balance of DHEA and cortisol make up the bodyĘs inner defense against the pressures of stress, helping your body adapt in a healthy manner.

How is your testosterone health?

• Are you over the age of 35?
• Are you under a lot of stress?Do you feel fatigued?
• Are your muscles sore for a long time after a workout?
• Have you noticed a waning sex drive?
• Have you gained weight, particularly around your mid-section?

Do you feel depressed, irritable or unmotivated?

If you answered yes to two or more of these questions, you could be suffering from male hormonal imbalance.

Find out for sure.

Based on more than twenty years of research, salivary hormone assessments have become a preferred method of measuring hormonal health. In addition to being less expensive and more practical than blood testing, salivary assessments measure the active (bioavailable) levels of hormones rather than the inactive (total or bound) levels of hormones.

Optimum hormonal health all starts with youthful levels of testosterone. Testosterone is what makes a man a man and keeps you healthy and vital throughout your whole life. Unfortunately, an abundance or recent research is showing that testosterone levels are declining faster in modern man than ever before. While researchers continue to debate the long-term significance of this growing problem more and more men are suffering from a life that is less full filling than they imagine as they grow older.

Take your health in your hands with the OptiMale Testosterone Health Check.

About Salivary Testing

The knowledge that there are steroid hormones in saliva, and that they can be measured, has been around for more than 30 years. But it is only recently that technology has caught up with that information making it possible to accurately determine levels of salivary hormones. Steroid hormone levels have and still are most commonly carried out on blood samples. But blood collection has its limitations. It is invasive, expensive and difficult to time precisely.

Perhaps more importantly, blood hormone levels represent the body's total hormone content. Since most blood hormones (about 95%) are bound to specific proteins which carry them through the bloodstream they can be considered the hormone 'storage' fraction. The other 5% represent the free hormones - those available to move easily into the target organs and fulfill their functions. Saliva contains these free hormones which can be easily measured to give an accurate picture of those hormones that are readily available to the tissues.

Many studies in the scientific literature have shown that there is a strong correlation between the levels of steroid hormones in saliva and the bio-available (free) levels of steroids in the bloodstream. The amount of steroid hormone that enters the salivary ducts and then saliva, is representative of the fraction of steroids in the bloodstream that are bio-available to other tissues in the body.

The Advantages of Saliva Testing
Saliva collection is easy, can be done anywhere, any time and very inexpensive. Serum hormone testing can be stressful and inconvenient. Blood testing must be scheduled and it is more difficult to obtain samples at the desired times (e.g. early am) and multiple times through the day or late evening. There is also an extra cost involved in drawing blood, independent of the cost for the test itself.

Hormones in saliva are exceptionally stable, allowing wide latitude in collection and shipment. Samples can be stored at room temperature for at least a week without loss of activity, so samples can be shipped to the testing facility by regular mail. Blood, on the other hand, must be kept cool on ice packs, increasing costs for shipping as well as the likelihood of error due to improper handling.

Collection and Processing
Five milliliters of saliva is requested. Following collection, saliva should be either frozen or shipped to the lab within one day of collection. Saliva is stable at ambient temperature for at least three weeks and a specimen received within that time is acceptable.

Test results are then generated and mailed within five to seven working days from date of receipt of the specimen to the laboratory, often sooner.

How Can Saliva Hormone Tests Help Your Patient?

The goal of saliva hormone monitoring is to determine whether or not hormone replacement therapy or another form of intervention is appropriate. If your patient is already taking hormones, testing will allow you to adjust dosages, both optimizing benefits and minimizing risks. And since your patient may opt to receive a copy of the test results directly, they will be able to play a more active role in their own health care and are more likely to adhere to the proposed hormone replacement intervention.

Why Test for Hormones?

• To establish a baseline before entering into a program of hormone supplementation
• To establish if there is a deficiency of hormones or an imbalance of hormones
• Confirmation that hormone supplementation is working
• To help confirm a medical diagnosis that may be hormone related

Advantage of Saliva vs. Serum Testing

• Closely Represents Physiological Levels
• Saliva reflects the biologically active (free) fraction of hormones in the blood stream (unlike blood
  or urine, which measures the total levels)
• Saliva testing allows for practical collection of multiple samples to assess the circadian (cyclical)
  rhythm of hormones such as testosterone and cortisol.

Patient Friendly

• Saliva testing is non-invasive, simple, stress free and painless. NO NEEDLES!
• Saliva can be convenient collected in the privacy and comfort of home.
• Saliva testing is less expensive than blood testing.
• Because hormones are stable in saliva for two weeks or more samples can be sent to the laboratory
  by regular mail without special handling

More Advantageous to the Doctor

• Specimen collection supplies can be provided to the practice in a timely manner.
• Technical and clinical support from MedLean
• Easy-to-read test results, graphs and ranges
• Rapid turnaround time of patient results
• Comprehensive professional guide for test result interpretation and technical information
• Availability of patient educational material

Interpretation of Saliva Hormone Ranges
Laboratory values can only be fully interpreted in the context of the complete clinical picture. Specific diagnoses cannot be made on the basis of laboratory values alone. In addition, for diurnally variable hormones or supplementation, the timing of collection of the specimen is critical. Normal ranges most be calibrated relative to a specific time of day (early AM) and to specific times relative to dosing of supplementation (trough levels). The normal ranges may not be valid for different collection regimens (i.e. PM collection or to capture peak levels).

Derivation of Ranges
Ranges are determined by testing both volunteers representing designated populations and drawing from an extensive patient database. Each range is based on as many as 800 analyses. These salivary hormone ranges capture 90% of normal female and male values leaving 5% below and 5% above the normal range. Correlation of these ranges with those in the literature for saliva steroid hormones is excellent.

Unsupplemented salivary hormone ranges represent normal physiologic levels for the groups of patients described (i.e. premenopausal, postmenopausal, specific age groups and gender for androgens). These ranges do not necessarily represent optimal levels for health since physiologically normal levels can be risk factors for pathologic processes in certain groups (postmenopausal low levels of estrogen put women at risk for bone fracture due to increased bone turnover).

Age-based testosterone hormone ranges are guidelines for targeting levels that give and sustain optimal health. Ranges normally given for older populations are representative of normal, unsupplemented hormone levels and not necessarily those which will provide maximum well being. Titration to more youthful target ranges is an important therapy issue to consider.

Supplemented salivary hormone ranges are derived from groups of people on usual dose ranges of standard medications. Thus, these ranges are expected rather than optimal ranges as delineated by clinical endpoints. Dose levels tend to be high rather than low and physiologic effect (i.e. relief of symptoms, decrease in bone turnover rates) can be expected from the lower end of expected dose ranges for supplementation in most patients.

Individual and Physiological Variability
Some ranges may seem broad but this variation aptly demonstrates the wide individuality of hormone levels. As to be expected, women have higher levels of the estrogens and progesterone than men, and cycling women have higher levels than menopausal women. Men, in general, have higher DHEA and testosterone levels than women, and in both sexes, the level of each drops dramatically with age. Healthy state cortisol levels remain constant throughout life, regardless of sex or age.

Time of Collection
The ranges represent saliva hormone levels from specimens collected in the early morning unless otherwise noted. Since testosterone, DHEA and cortisol express diurnal variation with levels highest just after waking, it is extremely important that patients indicate the time of collection for an effective hormonal evaluation. Saliva hormone ranges were developed with early AM collections (between 6-8 AM), and they may not be valid for collections taken outside this window of time. For patients taking supplementation, there is obvious pharmacokinetic variation relative to the time of dosing. If peak levels are desired, one may adjust the timing of collection to coincide with peak supplemented hormonal levels. However, Clinical Laboratory ranges are not adjusted to interpret peak levels.

Hormone Replacement Therapy (HRT) Pharmacokinetics

Delivery Systems
Oral HRT: Taken as tablets or capsules, oral HRT levels follow a cyclic pattern following ingestion. Oral doses, on average, result in peak levels about 2-6 hours following dosage, falling to the lowest, trough levels between 8-12 hrs.

Transdermal HRT: Hormones can be delivered transdermally or transmucosally (mouth, vagina or rectum) with a cream or gel. Saliva levels of hormones delivered transdermally (such as progesterone which is readily available over the counter in creams) are high relative to physiologic levels because of the following (see full explanation below):

Hormones are more fully absorbed through the skin than from the gut and do not experience the 'first liver pass' which breaks down over 80% of orally delivered hormones. Hormone-containing creams are applied in large amounts (as opposed to patches) and enter the system in a very short time.

When hormones are applied to the skin, we see very significant increases in salivary levels of that hormone, but often we see very little change in the serum level. This is because they are already in a biologically active form and quickly carried throughout the body by the bloodĘs fatty components such as chylomicrons or red blood cell membranes. They can be detected through the saliva within a few hours of applying the cream. Serum testing is a valid way to test hormones if they are produced within the body endogenously, or if you were taking hormones orally. However when hormones are applied to the surface of the skin, there is very little increase in serum levels but there's a remarkable increase in saliva levels. We believe the reason for this is that when hormones enter through the skin and enter the bloodstream, they're carried by red blood cells to target sites where they're delivered. When blood is collected, the red blood cells are spun down and removed, thrown away, and hormones tested in serum. Therefore, serum is not representative of the bioavailable fractions of hormones in the bloodstream in transdermal delivery. When using a transdermal cream, it's best to not use a cream for 12 to 24 hours before collecting the saliva specimen.

Patch HRT: HRT patches provide a continuous, steady-state delivery and are applied every 3-7 days for woman and daily for men. Patch-delivered hormones usually reach a peak by 24 hours followed by continuous levels for the duration of the recommended patch interval.

They deliver very small amounts of hormones slowly, thus do not overwhelm the binding capacity of the binding globulins. As expected, patches do not show a transdermal cream pattern but give levels that look like endogenous production or oral replacement at about 2 % of serum values.

Sublingual HRT: Sublingual delivery is similar to transdermal and the above explanation applies. However, caution during sample collection must be taken since occasionally the mouth will not clear the preparation and the saliva will be directly contaminated with hormone. If this is a problem, a PM collection prior to the next dose allows the mouth to clear during the day with increased oral activity. This collection modification will solve the problem in most cases.

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