USOO696.7194B1 (12) United States Patent (10) Patent No.: US 6,967,194 B1 Matsuo et al. (45) Date of Patent: Nov. 22, 2005 (54) BIO-IDENTICAL HORMONES AND 6,274,582 B1* 8/2001 M.angrin ................ 514/254.1 METHOD OF USE * cited by examiner (75) Inventors: Susan Matsuo, 7900 E. Greenlake Dr., Primary Examiner-Herbert J. Lilling North, Suite 200, Seattle, WA (US) (74) Attorney, Agent, or Firm-Buskop Law Group, P.C.; 98103; Teresa Leigh Barr, Port Wendy Buskop Townsend, WA (US) (57) ABSTRACT (73) Assignee: Susan Matsuo, Edmonds, WA (US) (*) Notice: Subject to any disclaimer, the term of this The invention is a method for balancing and maintaining patent is extended or adjusted under 35 Cortisol levels in humans by identifying the hormonal needs U.S.C. 154(b) by 551 days. for a human, using blood tests or Saliva tests to ascertain the current relationship between the DHEA, androstenedione, (21) Appl. No.: 10/246,358 testosterone and androstenediol for that human, inserting the low values of each hormone level into a hormone tree, (22) Filed: Sep. 18, 2002 balancing the DHEA with the androstenediol and the test (51) Int. Cl." ........................ Aok 31st. Aok 31ss forosterone the particularand the androstenediolin perSon, modifying a ratio the whichinserted is normalvalues (52) U.S. Cl. ...................... it's. individually forming modified values wherein the modified s s values account for a Selected Symptoms, changing the modi (58) Field of Search ................................ 514/171, 172, fied value to accommodate for SeX type of an individual 514/169,505, 184; 424/655, 450 forming a gender accommodated value, and creating a morning and evening dose that priors an amount of bio (56) References Cited identical hormones to bring the gender accommodated value U.S. PATENT DOCUMENTS up to the normal ratio. 5,888,553 A * 3/1999 Grant et al. ................ 424/655 6,221,379 B1 * 4/2001 Place ......................... 424/435 9 Claims, No Drawings US 6,967,194 B1 1 2 BIO-IDENTICAL, HORMONES AND Androstenedione (C19H26O2) is also known as Andro METHOD OF USE and Androstene. The Scientific names are 4-androstene-3, 17-dione; and androst-4-ene 3, 17-dione. Androstenedione's FIELD OF THE INVENTION mechanism of action is as a Steroid hormone produced by the adrenal glands, testes and ovaries. It is a direct precursor of The present invention takes the concept of bio-identical testosterone and estrogen in both men and women. Andros hormone replacement out of the mentality that associates tenedione production peaks in the mid-twenties and declines hormones only with Sexuality. The present invention encom steadily after the age of 30. It has been used to improve passes both nighttime and morning formulas to maintain athletic performance and to build muscle. Androstenedione optimal health for humans and animals. raises DHEA levels and also raises estrogen levels. Ande strenedione can be purchased from Hawkins, 3000 East BACKGROUND OF THE INVENTION Hennepin Avenue, Building 7, Department PH, Minneapo While hormones determine Sexual gender and develop lis, Minn., 55413, 800-375-0009. mental characteristics, they also fine-tune a perSon's capa 15 Cortisol is the primary glucocorticoid produced by the bility to function optimally in the body and mind. Viewing adrenal cortex gland. Ninety percent of the Cortisol Secreted the list of possible problems associated with hormone imbal in circulation is bound to protein, mainly to Cortisol-binding ance, it is clear that the effects are broad and far-reaching. globulin. Cortisol is a Steroid hormone that is released from They encompass all body/mind Systems. They are integral the Zona fasciculata of the adrenal cortex in response to for maintaining health and wellbeing. The present invention StreSS. Some of the Stressors that Stimulate release of this encompasses both nighttime and morning formulas to main glucocorticoid hormone include drastic changes in tempera tain optimal health for humans and animals. ture, or heavy exercising. Cortisol is considered Such a The present invention claims that hormones play a vital reliable indicator of StreSS upon a System that many physi role in maintaining Cortisol levels involved in good cogni ologists define StreSS as an event that elicits increased levels tive function Such as memory. Studies indicate hormones 25 of Cortisol. The release of Cortisol begins with the hypo may protect both men and women from cardiovascular thalamus. The hypothalamus receives input about StreSSors disease. Many find that when hormones are balanced natu affecting the System and transferS this information in rally and individually, they have leSS StreSS, more energy and through a chemical called corticotrophin-releasing hormone have a feeling of wellbeing. Bio-identical hormones are (CRH). CRH travels through a portal vessel to the anterior hormones that are: bio-identical to what humans naturally pituitary gland where it stimulates the release of adrenocor produce or produced at one time in their lives, can be ticotrophic hormone (ACTH). The ACTH then circulates to naturally made from plant Sources or of pharmaceutical the adrenal cortex where it stimulates the production and quality and therefore bio-available. The present invention release of Cortisol. Once Secreted into the general circula utilizes all types of hormones within its concepts. tion Cortisol inhibits the release of CRH and also inhibits 35 sensitivity to CRH thereby establishing a negative-feedback Correct individual hormone balance is the key to the present invention as well as determining the correct dosage control over the system. The actual effect of Cortisol on an of each hormone. Each perSon is different in his or her organism is to alter metabolic functioning and the body's requirements. Hormonal needs vary dramatically from one immune response. Increased Cortisol levels alter organic individual to the next. Each individual’s hormones fluctuate metabolism in a number of ways. It results in an increased 40 mobilization of amino acids from protein Stores in extra depending on changing levels of StreSS as well as other life hepatic (non-liver) cells. It also results in an increase in events. It is important to fine-tune hormone replacement and transport of these amino acids to the liver. The liver converts learn how to listen to a body's hormone needs. Too much or these amino acids to glucose through a process called too little will both lead to hormone imbalance. Optimum gluconeogenesis and uses the amino acids to increase pro feelings of wellness come from the correct individual 45 duction of plasma proteins. The increase in Cortisol levels balance. One can think of hormone balance as a teeter also serves to mobilize fatty acids from adipose tissues in an totter, where if one Section is out of Synchronization, one attempt to shift cells in the metabolic systems from the Side is too high and the other is too low. utilization of glucose for energy and to the utilization of fatty All hormones are found in both men and women. Each acids instead. In addition to its metabolic function, increased SeX has more of Some and less of otherS. Sexual gender and 50 levels of Cortisol Serve to Suppress the immune System. an individual's genes determine this ratio. Considering Increased levels of Cortisol Serve to decrease the production genetic history is important. The present invention uses the of lymphocytes and antibodies. Suppressing the immune following diagram to describe hormone balance as a hor System may be helpful in reducing Some damaging effects of monal tree. All hormones are derived from cholesterol. an immune response. The action of Cortisol has many The following paragraphs discuss Some of the chemicals 55 Significant medical implications. Cortisol could be used for asSociated with this invention. diabetics who may require more insulin when they are under Andrestenediolor Androdiol (C20H32O2) is also known StreSS to cope with the increase blood glucose levels. Sur as 4-AD, 4-androstenediol, or 5-androstendiol. The Scien geons must be aware that their patient's protein catabolism tific names for Andrestenediol include 4-androstenone may increase due to the Stressfulness of their situation, 3beta, 17 beta-diol and 5-androstene-3beta, 17 beta-diol. 60 which could be treated with Cortisol. Cortisol's ability to Mechanism of action in the body: there is evidence that SuppreSS the immune response may be exploited clinically to exogenous androstenediol is converted to testosterone in treat various inflammatory conditions Such as allergies and humans. One use of Andrestenediol is to increase endog arthritis. Cortisol may also be used in organ transplant enous testosterone in humans, it is a precursor hormone to operations to reduce the chance of organ rejection. Cortisol testosterone and estrogen. Andrestenediol can be purchased 65 is essential for life; it helps an organism cope more effi from LPJ Research, Inc., 352 Promontory Drive West, ciently in its environment. Cortisol is important in glucose Newport Beach, Calif., 92660, 949-566-9841. and energy balance as well as moderating inflammatory US 6,967,194 B1 3 4 response and immune mechanisms, in addition to many brain and induces changes in the Sleep EEG by increasing other functions. Cortisol is a critical hormone for controlling the time spent in Slow wave sleep. Sometimes pregnenolone StreSS. is called the “mother' of all hormones. It is the first hormone The body's level of Cortisol in the bloodstream displays made from cholesterol and is the precursor of all the rest of a diurnal variation, that is, normal concentrations of Cortisol the hormones in the hormone tree, See diagram 3. In other vary throughout a 24-hour period. Cortisol levels in normal words, wherever there is a deficiency in the hormone tree, individuals are highest in the early morning around 6:00-8: pregnenolone can be converted into that hormone to correct 00 am, and are lowest around midnight.