WO2004075901A2

WO2004075901A2 - Compositon for increasing levels of hormones and a method for preparation of said composition

Info

Publication number: WO2004075901A2
Application number: PCT/US2004/005537
Authority: WO
Inventors: Charles A. Mesko
Original assignee: Mesko Charles A
Priority date: 2003-02-25
Filing date: 2004-02-24
Publication date: 2004-09-10
Also published as: WO2004075901A3

Abstract

A pharmacologically acceptable composition for topical administration for a mammal for raising hormone levels in the subject mammal. The composition includes a first ingredient including an element that may be a hormone, such as testosterone or growth hormone, or a hormone-potentiating element to stimulate the subject’s own production of hormones, such as testosterone or growth hormone. The composition further includes a vesicle operable for transporting said first homeopathic ingredient from a first site external to a body to a second site internal to said body.

Description

COMPOSITION FOR INCREASING LEVELS OF HORMONES AND A METHOD FOR PREPARATION OF SAID COMPOSITION

Field of the Invention

The present invention relates generally to a composition for varying the levels of hormones in a mammal and specifically to a composition for topical administration and absorption into the human system, that results in increased levels of human growth hormone and/or testosterone.

Background of the Invention

Human growth hormone (somatropin) is a physiological substance produced in the anterior lobe of the pituitary gland of the human system. It is the most abundant hormone produced by the anterior pituitary lobe, accounting for as much as eight to ten percent of the dry weight of the gland. The physiological effects of human growth hormone are macroscopic, extending beyond cellular, chemically mediated events. One example of this is the effect of human growth hormone on whole body growth. Growth hormone effects an increase in tissue and organ weight, which results from an increase in mitosis, cellular hypertrophy, hyperplasia and cellular water. Growth hormone also

stimulates the increased uptake of amino acids into cells, resulting in protein synthesis. Growth hormone is responsible for proper growth and development until adulthood and then regulates nearly every organ in the body. Growth hormone also has prosexual effects, such as enhanced sexual performance and a decrease in the incidence of impotence in males. Studies have suggested that an estimated 70%-80% of cases of erectile dysfunction may be caused by increased levels of prolactin, another hormone released by the

I pituitary gland. Growth hormone release from the pituitary gland can be associated with a decrease in the release of prolactin.

Growth hormone is synthesized in the acidophilic somatotropes, which are specialized cells located in the anterior of the pituitary gland.

Secretion of the growth hormone by the pituitary gland is episodic. The anterior pituitary operates in conjunction with the hypothalamus and adrenal glands as an integrated unit. The large array of physiological factors that effect growth hormone secretion act on the pituitary gland through the hypothalamus. The hypothalamus controls this secretion by causing the release of either growth hormone release stimulating or inhibiting factors. These factors result in the release or retention of human growth hormone by the pituitary gland.

Human growth hormone was first discovered by researchers in the 1920s, and due to its effects on whole body growth, was considered to be a promising therapeutic agent. In 1958, growth hormone extracted from the pituitary glands of cadavers was injected into a growth stunted child at the New England Medical Center in Boston, Massachusetts. As a result, the child grew taller and popularity for the use of growth hormone in medical applications grew. However, one major drawback of the natural growth hormone, is that heat destroys the pituitary extract. Thus, it cannot be pasteurized to eliminate the possibility of disease transmission. Therefore, before the use of growth hormone as a therapeutic agent could become widespread, it either had to be sterilized or a synthetic hormone had to be produced to reduce the potential for transmission of disease.

In 1986, the Eli Lilly Company developed "Humatrope", a manmade growth hormone identical in structure to the actual human growth hormone. Soon after, in 1990, the New England Journal of Medicine released the results of a six month clinical study on human growth hormone administered to a group of men aged 61 to 81. Without exercise, these men lost body fat and wrinkles and gained lean muscle, along with a thickening of the skin and a regeneration of failing liver tissue.

Testosterone is another physiological substance produced by the human body and is responsible for normal growth and development of male sex organs and maintenance of secondary sex characteristics. It is the primary androgenic hormone, and its production and secretion by the testes are the end product of a series of hormonal interactions referred to as the hypothalamic- pituitary-gonadal axis. Gonadotropin-releasing hormone (GnRH) is secreted by the hypothalamus to the pituitary gland in carefully timed pulses. This triggers the pulsatile secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) by the anterior pituitary. Luteinizing hormone regulates the production and secretion of testosterone by the Leydig cells of the testes and FSH stimulates spermatogenesis. When the testes fail to produce normal levels of testosterone, testosterone deficiency results. Hypergonadotropic hypergonadism is caused by primary testicular failure. Testosterone levels are low and pituitary gonadotropins are elevated. In secondary, more hypogonadotropic hypergonadism, there is inadequate secretion of pituitary gonadotropins. In addition to a low testosterone level, LH and FSH levels are low or low-normal. While prepubertal hypergonadism is generally characterized by infantile genitalia and lack of virilization, the development of hypogonadism after puberty frequently results in complaints such as diminished libido, erectile dysfunction, infertility, gynecomastia, impaired masculinization, changes in body composition, reductions in body and facial hair, and osteoporosis. In addition to these complaints, mood inventory scores indicate that hypogonadal men report levels of anger, confusion, depression, and fatigue that are significantly higher than those reported by men with normal testosterone levels. Testosterone levels begin to decline in men at about age 25.

Deficiency symptoms include decreased sex drive, loss of muscle mass and strength, decreased bone density, lessened self esteem, and increased body

fat.

Thus, human growth hormone and/or testosterone may be used for therapeutic and possibly cosmetic benefits in persons who have deficient hormone levels. As a result, there has been an increased demand for growth hormone and/or testosterone treatments. However, a number of problems are associated with such use. First, cost is a factor. For example, increased levels of growth hormone have been provided through the injection of human growth hormone (natural or synthetic) from a foreign source directly into the human subject. However, such injections are prohibitively expensive, costing anywhere from $1 ,200 to $3,500 per month. Likewise, similar treatments with testosterone may also come at an increased cost. Additionally, when the delivery method is via injection, the injections have to be performed in a medical environment under a physician's supervision. This requirement not only adds to the cost of the treatment, but is also inconvenient to the patient's schedule.

Second, increasing levels of a foreign hormone, such as growth hormone or testosterone, within a subject also may result in negative side effects. For example, in the case of growth hormone, in response to the injection of a foreign growth hormone, the hypothalamus triggers elevated levels of somatostatin, a growth hormone release inhibitor, which then prompts the pituitary gland of the subject individual to curb the release of its naturally produced growth hormone. Of course, it is undesirable to inhibit the natural release of the growth hormone from the pituitary gland in favor of the synthetic hormone. This is because the release of natural growth hormone from the pituitary gland is controlled by negative feedback involving growth hormone releasing and release inhibiting factors. If growth hormone levels are low, the pituitary gland is stimulated by releasing factors in the hypothalamus to increase the release of natural growth hormone. If growth hormone levels are high, the pituitary gland is inhibited from releasing natural growth hormone by the release inhibiting factor, somatostatin, from the hypothalamus. Thus any addition of growth hormone to the human system, whether natural or synthetic, will impact this negative feedback loop, thereby disrupting the balance of growth hormone levels achieved by the tandem operation of hypothalamus and pituitary gland. As a result, the pituitary gland may slow down or even cease production and release of the natural growth hormone, and the normal function of the pituitary gland of the subject is disrupted.

The addition of any testosterone to the human system may also negatively affect the body's natural production of testosterone by curtailing the production of testosterone. Thus, any addition of testosterone to the human system, whether natural or synthetic, will impact the body's negative feedback loop as it relates to the production of testosterone, thereby disrupting the balance of testosterone levels achieved by the operation of the hypothalamic- pituitary-gonadal axis. As a result, the testes may slow down or even cease production and release of natural testosterone, and the normal function of the hypothalamic-pituitary-gonadal axis of the subject is disrupted. Additionally, another problem with traditional testosterone supplement preparations is the body's own natural defense mechanism to convert higher levels of testosterone into estrogen. Thus, when testosterone levels increase, the body responds by aromatizing the excess testosterone into estrogen. This may result in artificially high levels of estrogen in a subject.

Due to the aforementioned drawbacks with current procedures for increasing hormone levels, such as growth hormone and testosterone within the body, it is desirable to increase hormone levels in the human system without negatively affecting the natural production and release of those hormones by the body. Thus, it is desirable to increase growth hormone levels in the human system without negatively affecting the natural production of growth hormone by the pituitary gland. Likewise, it is desirable to increase testosterone levels in the human system without negatively affecting the natural production and release of testosterone by the testes. It is also desirable to increase hormone levels in a manner which does not require physician supervision. It is further desirable that any such composition or method to achieve such objectives be available at a low cost. Finally, it is desirable for any composition to involve a delivery system that protects the components from degradation in order to achieve a heightened efficiency in increasing growth hormone levels and/or testosterone levels in the human system.

Summary of the Invention The present invention solves the problems in the prior art and addresses the above objectives by increasing levels of hormones, such as human growth hormone and/or testosterone, within the human body. The present invention includes a pharmacologically acceptable composition for topical administration to a mammal, having a first ingredient including a hormone, and further having a vesicle operable for transporting the hormone from a first site external to a body to a second site internal to the body. In one embodiment, the hormone included in the first ingredient may be testosterone. In another embodiment, the hormone included in the first ingredient may be growth hormone. In yet another embodiment, the present invention may include first and second ingredients, each including hormones. In this embodiment, the hormone of the first ingredient may be testosterone, and the hormone of the second ingredient may be growth hormone. The hormone provided in the composition of the present invention may be present in homeopathic form. In another aspect of the present invention, the first ingredient of the composition may be an ingredient that potentiates the production and increased levels of a particular hormone. In one embodiment, this ingredient may potentiate the production and release of natural testosterone. In another embodiment, this ingredient may potentiate the production and release of natural growth hormone. In yet another embodiment, this ingredient may potentiate the production and release of a plurality of hormones, such as testosterone and growth hormone. In still another embodiment, the composition may include first and second ingredients to potentiate a hormone. In such an embodiment, the first ingredient may potentiate testosterone and the second ingredient may potentiate growth hormone. Alternatively, the first and second ingredients may both potentiate testosterone, or may both potentiate growth hormone.

In a particular embodiment regarding this potentiating aspect, the present invention includes a pharmacologically acceptable composition for topical administration to a mammal wherein the composition includes a first herbal extract which may include either an element for synthesizing a catecholamine, or have an active component comprising a luteinizing agent. The composition further includes a vesicle operable for transporting the first herbal extract across a membrane of the mammal. In yet another embodiment, the composition may include a first herbal extract including an element for synthesizing a catecholamine, and a second herbal extract having an active component comprising a luteinizing agent.

There are several factors which may stimulate growth hormone release by the pituitary. One group of releasing factors includes catecholamines, which are amine derivatives of dihydroxybenzene (or catechol), including norepinephrine, epinephrine and dopamine. Upon introduction to the body, the composition of the present invention may act to affect the production of dopamine within the human system.

The presence of dopamine in the human system stimulates the release of growth hormone by the pituitary gland. Thus, levels of dopamine may be increased by a first herbal extract of the composition of the present invention which contains dihydroxyphenylalanine (L-dopa). Once introduced into the human system, L-dopa converts to dopamine and stimulates an increase in serum concentration levels of growth hormone. By using dopamine to stimulate the release of the human system's own naturally-occurring growth hormone, the composition of the present invention avoids disrupting the normal function of the pituitary gland through the use of a foreign growth hormone which is a problem with prior art methods and compositions. L-dopa is also an effective inhibitor of the release of the hormone prolactin by the pituitary gland. Increased levels of prolactin in the human system are responsible for an estimated 70% - 80% of erection failures in males. Therefore, inhibiting prolactin release in accordance with the principles of the invention will limit erection failures in males.

The luteinizing agent of this embodiment of the present invention may act as an active component. These luteinizing agents may be saponins and/or alkaloids. These luteinizing agents may affect the hypothalamic- pituitary-gonadal axis to increase levels of natural testosterone. In particular, the presence of luteinizing agents may serve, like luteinizing hormones, to regulate the production and secretion of testosterone by the Leydig cells of the testes. Additionally, in the embodiment of the composition including both first and second herbal extracts, the combination of the first and second herbal extracts prevents the L-dopa of the first herbal extract from breaking down in the human system and also helps to maintain the presence of dopamine in the human system for an extended period of time. Further, in this embodiment of the present invention, the combination of the first and second herbal extracts of the present invention helps to block the release of somatostatin. As described above, somatostatin is a factor that inhibits the release of growth hormone. As the concentration of growth hormone in the human system rises, the hypothalamus releases somatostatin to control growth hormone levels, as part of the negative feedback loop discussed above. Any release of somatostatin operates counter to the benefits of higher concentrations of growth hormone that the present invention provides. Thus, by blocking the release of somatostatin, the combination of herbal extracts of the present invention maximizes levels of growth hormone in the human system.

As described above, in the embodiment of the composition for potentiating testosterone, the luteinizing agents of this embodiment of the present invention may stimulate the hypothalamic-pituitary-gonadal axis. In particular, this may stimulate the secretion of luteinizing hormone by the anterior pituitary, which increases the production and secretion of testosterone by the Leydig cells of the testes. As described above, one drawback to increased levels of testosterone is that the body may convert testosterone into estrogen. Thus, in another aspect of the present invention, the composition may include estrogen blockers to reduce and eliminate the body's own conversion of excess testosterone into estrogen. In another aspect, as described briefly above, the composition of the present invention is provided in a form suitable for topical administration. The composition may thus proceed from a first site external to the body to a second site internal to the body by being absorbed transdermally. In this

manner the composition addresses several drawbacks associated with prior art treatments involving the injection of growth hormone. For example, by eliminating the need for injection treatments, the present invention eliminates the need for physician supervision. This results in a reduction of inconvenience for the patient who, in receiving injections, had to manipulate schedules to include a doctor's appointment and had to endure what many patients consider to be discomforting: a needle injection. By providing the composition of the present invention in a form suitable for topical administration, the high costs of treatment associated with injection treatments are likewise reduced.

Thus, the present invention also includes a method of preparing a pharmacologically acceptable composition for topical administration to a mammal. This method includes providing a hormone. In one embodiment, this hormone may be testosterone. In another embodiment, this hormone may be growth hormone. The hormone may be provided in homeopathic form. This hormone is combined with a plurality of active homeopathic ingredients. These active homeopathic ingredients may be liquified or, alternatively, may be solid. The combination of homeopathic hormone and active homeopathic ingredients may then be encased in liposomes by processes well known to those having skill in the relevant art.

Thus, by this process, the ingredients of the present invention may be included in various compositions adapted to be topically applied to the skin in the form of moisturizers, creams, lotions, gels, ointments, emulsions, etc. This allows the homeopathic hormones to enter the body transdermally, thus eliminating the potential breakdown of the hormones that occurs when ingested orally, and eliminating the injection of hormones, physician supervision, etc. and attendant high costs.

The present invention also provides a method of increasing the level of a particular hormone, such as testosterone or growth hormone, in a mammal by administering the composition transdermally through topical administration. The above and other objects and advantages of the present invention shall be made apparent from the following detailed description.

Detailed Description of The Invention

The present invention, in one aspect, comprises a pharmacologically acceptable composition for topical administration to a mammal. This composition, in one embodiment, includes a first ingredient including a hormone and a vesicle operable for transporting the first ingredient from a first site external to a body to a second site internal to said body. The vesicle, which may be part of a plurality of vesicles, allows the hormones to enter the body transdermally, thus eliminating the potential breakdown of the hormones that occurs when ingested orally. This method of delivery also avoids the problems associated with hormone injections as discussed above in the background of the invention. The application of the composition results in increased levels of hormones in the human body. In one embodiment, the hormone included as an ingredient in the composition of the present invention may be provided in homeopathic form. Attaining this homeopathic form will be described in greater detail below.

In a first embodiment of the present invention, the hormone included in the first ingredient may be testosterone. As described above, the testosterone may be provided in homeopathic form. The approach of homeopathy is to trigger the body's rejuvenation with the smallest possible dosage that will stimulate healing response in a patient. This results in products that do not produce side effects, will not react to allopathic formulations, and do not cause habitual use or dependency. In the embodiment including homeopathic testosterone, the homeopathic testosterone is present in the composition in an amount sufficient to increase levels of testosterone within the human system. In various embodiments of the present invention, the testosterone may be present in different potencies. In one embodiment, testosterone may be provided in a potency of 10X. In an alternate embodiment, the potency may be 30X. In yet another embodiment, the potency may be 100X. As those of skill in the art will recognize, each homeopathic ingredient is first obtained as an "original tincture" which includes 10g of active ingredient, in this case testosterone, dissolved in 90g of solvent (a 10% solution). Next, the solution is repeatedly diluted. The strength of a solution increases with the degree of dilution. This may be expressed in "X" (a decimal dilution) or "C" (a centesimal solution). Thus, 1X means a 1 :10 dilution (one part of the original material in nine parts solvent). Thus, a 10X potency is a 1-to-10 dilution repeated ten times.

One drawback to testosterone supplementation, as described above in the Background of the Invention, is that a human body will curtail its normal testosterone production when foreign testosterone is introduced. The present invention may eliminate this problem by including a second ingredient to stimulate natural testosterone production and release. This second ingredient may have an active ingredient comprising a luteinizing agent for stimulating the production of a hormone by said body. In one embodiment of the present invention, this second ingredient may be an herbal extract. One example of such an herbal extract that may be used as the second ingredient is Tribulus L. Terrestris. The Tribulus L. Terrestris may stimulate the secretion of luteinizing hormones from the anterior pituitary gland, which triggers testosterone production. In one embodiment, the Tribulus L. Terrestris may be present in the composition of the present invention in an amount of at least .25% by volume. In one particular embodiment, for example, 300 mg of Tribulus L. Terrestris may be present in 4 oz. (118 ml) solution of the composition.

In yet another embodiment of the present invention, the second ingredient may be Mucuna Pruriens. Mucuna Pruriens contains L-dopa. The L-dopa naturally contained in the Mucuna Pruriens triggers the hypothalamic- pituitary-gonadal axis to stimulate natural testosterone production and release. In one embodiment, the Mucuna Pruriens may be present in the composition of the present invention in an amount of at least 1.5% by volume. In one particular embodiment, for example, 1500 mg of Mucuna Pruriens may be present in 4 oz. (118 ml) solution of the composition.

In yet another embodiment of the present invention, the second ingredient may be Eurycoma Longifolia Jack. Eurycoma Longifolia Jack stimulates natural testosterone production and release. In one embodiment, the Eurycoma Longifolia Jack may be present in the composition of the present invention in an amount of at least .25% by volume. In one particular embodiment, for example, 300 mg of Eurycoma Longifolia Jack may be present in 4 oz. (118 ml) solution of the composition.

Yet other materials may be added as the second ingredient of the composition of the present invention. These materials may include, but are not limited to, ginko biloba and Horny Goat Weed.

Another major problem with traditional testosterone preparations, as described above, is the body's own natural defense mechanism to convert higher levels of testosterone into estrogen. When testosterone levels increase, the body responses by aromatizing the excess testosterone into estrogen. The composition of the present invention eliminates this problem, in one embodiment, by including an estrogen blocker in the formula of the composition. In one embodiment of the present invention, this estrogen blocker may be chrysin. Chrysin has its activity in filling estrogen receptor sites, thereby preventing estrogen production. In one embodiment of the present invention, the chrysin may be present in the composition in an amount of at least .25% by volume. In one particular embodiment, for example, 300 mg chrysin may be present in 4 oz. (118 ml) solution of the composition.

In another embodiment of the present invention, the estrogen blocker may be diindolymethane. Diindolymethane is a cruciferous extract which fills carcinogenic estrogen receptor sites. Estrogen production decreases when estrogen receptor sites are occupied and cannot be used. This results in sustained increased testosterone levels. In one embodiment, the diindolymethane may be present in the composition of the present invention in an amount of at least .05% by volume. In one particular embodiment, for example, 60 mg diindolymethane may be present in 4 oz. (118 ml) solution of the composition. In yet another embodiment of the present invention, the composition of the present invention may include a plurality of estrogen blockers. This plurality of estrogen blockers may include, but is not limited to, chrysin and diindolymethane. In such an embodiment, chrysin may be present in the composition in an amount of at least .25% by volume, and diindolymethane may e present in an amount of .05% by volume.

In addition to the first ingredient including a hormone provided in the composition of the present invention, the composition may also include a plurality of additional active homeopathic ingredients. These active homeopathic ingredients may create a synergistic effect of the composition which is more effective than using each ingredient individually. In one embodiment of the present invention, the composition includes a combination of testosterone, which may be homeopathic testosterone, and which may be delivered to the body along with a plurality of other active homeopathic ingredients, some of which may offer similar benefits that mimic testosterone, and some of which may cause the body to produce more testosterone by causing the stimulation of the body's own testosterone production. In one embodiment of the present invention, the composition may include these active homeopathic ingredients as liquefied prior to introduction into vesicles for topical administration to the body.

In the embodiment of the composition of the present invention including testosterone as the hormone in the first ingredient, the plurality of active homeopathic ingredients may include one or more of adrenalinum, alfalfa, avena sativa, baryta carbonica, baryta iodata, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, lycopodium clavatum, and thuja occidentalis. In one embodiment, each of these active homeopathic ingredients may be present in concentrations of 10X. In an alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 30X. In yet another alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 100X. In one particular embodiment of the present invention including testosterone, the composition may include each of adrenalinium, alfalfa, avena sativa, baryta carbonica, baryta iodata, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, lycopodium clavatum, and thuja occidentalis, as the plurality of active homeopathic ingredients. These active homeopathic ingredients may be present in equal amounts, with each active homeopathic ingredient being present in a concentration of 10X. In an alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 30X. In yet another alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 100X. The above listed plurality of active homeopathic ingredients may include, but are not limited to, the following effects. Adrenalinum increases circulation and improves energy. Alfalfa influences nutrition and improves appetite and digestion. This improves mental and physical vigor with gain in weight. It also promotes a general feeling of well being. Avena sativa

influences nutritional function in the brain and nervous system and provides relief for nervous exhaustion. It also causes relief of male impotency, improves strength in hands and limbs, and focuses the mind. Baryta carbonica promotes normal heart function and combats loss of memory and general mental weakness. Baryta carbonica also enhances libido and prevents impotence. It may prevent pain in joints and cramps in muscles. Baryta iodata helps to promote a healthy lymphatic system. Baryta muriatica acts on muscles and joints to prevent stiffness. Calcarea carbonica provides its main action on glands, skin, and bones. It aids in the reduction of body fat. It also may be used to alleviate headaches from overlifting, mental exertion, and nausea. Calcarea fluorica is a tissue remedy for enlarged glands, varicose and enlarged veins, and malnutrition of bones. It may also be used for relief of nausea. Calcarea phosphorica is used to eliminate stiffness and pain in joints and bones. Lycopodium clavatum is a remedy affecting the digestive tract. It is also used to remedy poor circulation. This herb also helps to focus brain power. Thuja occidentalis acts on skin, blood, gastrointestinal tract, kidneys, and brain. It is used for the relief of emotional sensitivity and for muscular twitchings, weakness, trembling, cracking in joints and pain in heels, and for persistent insomnia.

In yet another embodiment, the present invention may further include somatropin. This somatropin is otherwise known as human growth hormone and may be used in combination with the first ingredient including testosterone in order to raise levels of both testosterone and growth hormone in the human body. In one embodiment, somatropin may be present in the composition of the present invention in a concentration of 10X. In an alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 30X. In yet another alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 100X.

In yet another embodiment, the present invention may further include IGF-1. In this embodiment, IGF-1 may be present in the composition of the present invention in a potency concentration of 12C. In addition to the ingredients listed above, the composition of the present invention may include a plurality of inactive ingredients. In one embodiment, the plurality of inactive ingredients may include one or more of epimedium extract, aloe barbadensis extract, polyacrylamide, C13-14 isoparaffin, laureth 7, lecithin, saw palmetto extract, and diazolidinyl urea. In one particular embodiment, the composition may include each of the above listed inactive ingredients. These inactive ingredients may be present in equal amounts, such as at least .05% by volume each, or, alternatively may be present in varying amounts.

In a second embodiment of the present invention, the hormone included in the first ingredient may be growth hormone. In the embodiment including growth hormone present in homeopathic form, the homeopathic growth hormone is present in the composition in an amount sufficient to increase levels of growth hormone within the human system. In various embodiments of the present invention, the growth hormone may be present in different potencies. In one embodiment, growth hormone may be provided in a potency of 10X. In an alternate embodiment, the potency may be 30X. In yet another embodiment, the potency may be 100X.

One drawback to growth hormone supplementation, as described above in the Background of the Invention, is that a human body will curtail its normal growth hormone production when foreign growth hormone is introduced. The present invention may eliminate this problem by including a second ingredient to stimulate natural growth hormone production and release. This second ingredient may have an active ingredient comprising a luteinizing agent for stimulating the production of a hormone by said body. In one embodiment of the present invention, this second ingredient may be an herb or herbal extract. One example of such an herb or herbal extract that may be included in the present invention is Tribulus L. Terrestris. The Tribulus L. Terrestris may stimulate the secretion of luteinizing hormones from the anterior pituitary gland, which triggers growth hormone production. In one embodiment, the Tribulus L. Terrestris may be present in the composition of the present invention in an amount of at least .25% by volume. In one particular embodiment, for example, 300 mg of Tribulus L. Terrestris may be present in 4 oz. (118 ml) solution of the composition.

In yet another embodiment of the present invention, the second ingredient may be Mucuna Pruriens. Mucuna Pruriens contains L-dopa. The L-dopa naturally contained in the Mucuna Pruriens triggers the body to stimulate natural growth hormone production and release. In one embodiment, the Mucuna Pruriens may be present in the composition of the present invention in an amount of at least 1.5% by volume. In one particular embodiment, for example, 1500 mg Mucuna Pruriens may be present in 4 oz. (118 ml) solution of the composition. In yet another embodiment of the present invention, the second ingredient may be Eurycoma Longifolia Jack. Eurycoma Longifolia Jack stimulates natural testosterone production and release. In one embodiment, the Eurycoma Longifolia Jack may be present in the composition of the present invention in an amount of at least .25% by volume. In one particular embodiment, for example, 300 mg of Eurycoma Longifolia Jack may be present in 4 oz. (118 ml) solution of the composition.

The composition including growth hormone may also include a plurality of active homeopathic ingredients. These active homeopathic ingredients may create a synergistic effect of the composition which is more effective than using each ingredient individually. In one embodiment of the present invention, the composition includes a combination of homeopathic growth hormone which may be delivered to the body along with a plurality of other active homeopathic ingredients, some of which may offer similar benefits that mimic growth hormone, and some of which may cause the body to produce more growth hormone by causing stimulation of the body's own growth hormone production. In one embodiment of the present invention, the composition these ingredients may be liquified prior to the introduction into the vesicles for topical administration to the body.

In the embodiment of the composition of the present invention including growth hormone in the first ingredient, the plurality of active homeopathic ingredients may include one or more of abrotanum, anacardium, orientale, arsenicum album, baryta carbonica, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, ferrum metallicum, fucus vesiculosus, hekla lava, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidium, secale cornutum, and silicea. Each of these active homeopathic ingredients may be present in concentrations of 10X. In an alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 30X. In yet another alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 100X. In one particular embodiment of the present invention including growth hormone in the first ingredient, the composition may include each of abrotanum, anacardium orientale, arsenicum album, baryta carbonica, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, ferrum metallicum, fucus vesiculosus, hekla lava, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidium, secale cornutum, and silicea, as the plurality of active homeopathic ingredients. These active homeopathic ingredients may be present in equal amounts, with each active homeopathic ingredient being present in a concentration of 10X. In an alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 30X. In yet another alternate embodiment, each of the active homeopathic ingredients may be present in concentrations of 100X. Many of the above listed plurality of active homeopathic ingredients include, but are not limited to, the following effects. Abrotanum is a remedy which may be used to tighten skin and eliminate pain in stomach. It may also be used to eliminate dry cough and a raw feeling in the throat. Anacardium orientale is a remedy to eliminate hunger and nervousness. Arsenicum album is a skin remedy for itching, burning, swelling, eruption, dry, rough or scaly symptoms. It is also useful in the treatment of psoriasis. Baryta carbonica promotes normal heart function and combats loss of memory and general mental weakness. Baryta carbonica also enhances libido and prevents impotence. It may prevent pain in joints and cramps in muscles. Baryta iodata helps to promote a healthy lymphatic system. Baryta muriatica acts on muscles and joints to prevent stiffness. Calcarea carbonica provides its main action on glands, skin, and bones. It aids in the reduction of body fat. It also may be used to alleviate headaches from overlifting, mental exertion, and nausea. Calcarea fluorica is a tissue remedy for enlarged glands, varicose and enlarged veins, and malnutrition of bones. It may also be used for relief of nausea. Calcarea phosphorica is used to eliminate stiffness and pain in joints and bones. Ferrum metallicum is another remedy to eliminate pallor of the skin, mucous membranes, and flushed skin. It also sharpens mental focus and grants relief from headaches, ringing in the ears, and pain extending to the teeth and scalp. Fucus vesiculosus is a specific remedy for obesity in that it aids digestion. Hekla lava aids in the treatment of bone necrosis. Helleborus niger strengthens muscles and improves mental capacity. It may also be used to tighten and tone the skin. Ignatia amara ameliorates hunger and cramps in the stomach. It is also useful for alleviating nervous temperament, sensitivity, and an easily excited nature. Lycopodium clavatum is a remedy for urinary or digestive disturbance. Nicotinamidum relieves the inability to think or fix attention on a particular subject. It also aids in relief of indistinct vision and sensitivity of eyes to light and indistinct hearing. Secale cornutum is a remedy for the tightening of the skin. It also encourages restful sleep. Silicea is used for relief for imperfect assimilation and defective nutrition. It also aids in relief of pale, waxy skin, and rose-colored blotches. It also improves mental capacity. In addition to the ingredients listed above, the composition of the present invention may include a plurality of inactive ingredients. In one embodiment, the plurality of inactive ingredients may include one or more of aloe barbadensis extract, polyacrylamide, C13-14 isoparaffin, laureth 7, lecithin, vitamin E acetate, sodium ascorbol phosphate, vitamin A, vitamin D3, vitamin B2, and diazolidinyl urea. In one particular embodiment, the composition may include each of the above listed inactive ingredients. These inactive ingredients may be present in equal amounts, such as at least .05% by volume each, or, alternatively, may be present in varying amounts. Further, in yet another embodiment of the present invention, the composition of the present invention may include both testosterone and human growth hormone. In various embodiments of the present invention, the testosterone and growth hormone may be present in different potencies. In one embodiment, testosterone and growth hormone may be provided in a potency of 10X. In an alternate embodiment, the potency may be 30X. In yet another embodiment, the potency may be 100X. In another aspect, the present invention may include a pharmacologically acceptable composition for topical administration to a mammal, including a first ingredient adapted to potentiate a hormone. Further, this composition may include at least one vesicle operable for transporting the first ingredient from a first site external to a body to a second site internal to a body. In a particular embodiment regarding this potentiating aspect of the composition of the present invention, the first ingredient may include a first herbal extract. This first herbal extract may include an active component comprising a luteinizing agent or, alternatively, may include an element for synthesizing a catecholamine.

As described above, in the Summary of the Invention, there are several factors which stimulate growth hormone release by the pituitary. One group of releasing factors includes catecholamines. These act to affect the production of dopamine within the human system which leads to the increased production of growth hormone. Additionally, as described above in the Summary of the Invention, luteinizing agents may affect the hypothalamic- pituitary-gonadal axis to increase levels of natural testosterone. Luteinizing agents may further lead to an increased level of growth hormone in the human body by blocking the breakdown of L-dopa, which leads to increased dopamine uptake. Thus, the hormone which is potentiated by this embodiment of the present invention may be either testosterone or growth hormone or both.

In another aspect, the present invention may include a pharmacologically acceptable homeopathic composition for topical administration to a mammal including a first herbal extract including an element for synthesizing a catecholamine; a second herbal extract having an active component comprising a luteinizing agent; and a vesicle operable for transporting said first and second herbal extracts across a membrane of said mammal. In one embodiment, this first herbal extract may be a hydroxylated amino acid, which may be L-dopa. Additionally, the catecholamine to be synthesized may be dopamine. In one embodiment, the first herbal extract may be of Mucuna

Pruriens. The L-dopa may be present in said Mucuna Pruriens extract in an amount of at least about twenty percent by volume.

In one embodiment, the second herbal extract is Tribulus L. Terrestris. Thus, the composition of the embodiment of the present invention wherein the element for synthesizing a catecholamine includes L-dopa, the L- dopa is operable to stimulate said mammal to synthesize dopamine, and the Tribulus L. Terrestris extract is operable to prevent L-dopa from degrading in the mammal, thereby enhancing dopamine uptake in the mammal.

As described above, the first herbal extract of an embodiment of the composition of the present invention may be an extract of the herb Mucuna Pruriens. Mucuna Pruriens contains the hydroxylated amino acid dihydroxyphenylalanine (L-dopa) and is especially useful in the composition of the present invention in that the percentage of L-dopa found in Mucuna Pruriens is unusually high as compared to the L-dopa concentration in other herbs. The extraction process further increases the concentration of L-dopa. The final amount of L-dopa in the Mucuna Pruriens extract used in the composition is at least about twenty percent by volume.

L-dopa is the active element in the composition of the present invention in stimulating the release of natural growth hormone by the pituitary gland. L-dopa is a product of the hydroxylation of the amino acid tyrosine by tyrosine hydroxylase to produce dihydroxyphenylalanine (L-dopa). Once L- dopa has been absorbed through the intestinal wall into the blood stream, it crosses the blood-brain barrier where it is then decarboxylated by the enzyme L-aromatic amino acid decarboxylase to produce dopamine, a growth hormone releasing factor. The dopamine then acts upon the hypothalamus and pituitary gland to stimulate an increase in serum concentration levels of natural human growth hormone.

As described above, the second herbal extract used in combination with the first herbal extract in one embodiment of the composition of the present invention may be an extract of Tribulus L. Terrestris. Tribulus L. Terrestris is present in the composition in both herb and extract form. This component contains saponins and alkaloids which function as luteinizing agents to prevent the L-dopa of the Mucuna Pruriens extract from degrading within the human system before crossing the blood-brain barrier to convert to dopamine by the aforementioned decarboxylation process. The Tribulus L. Terrestris has additional functions when operating in combination with Mucuna Pruriens extract in accordance with the principles of the present invention. The combination of the herbal extracts Mucuna Pruriens and Tribulus L. Terrestris results in improved levels of uptake of L- dopa by the human system. The two extracts operating in concert in the inventive combination also inhibit the release of somatostatin. As previously discussed, somatostatin is a growth hormone release inhibiting factor found in the hypothalamus. Somatostatin blocks the release of natural growth hormone by the pituitary gland. By inhibiting the release of somatostatin, the combination of herbal extracts of the present invention maintains the presence of dopamine in the human system for an extended period of time. These increased levels of dopamine stimulate an increase in the release of natural growth hormone by the pituitary gland. The operation of Mucuna Pruriens extract and Tribulus L. Terrestris in combination thus maximizes serum concentration levels of natural human growth hormone in the human system. Another aspect of the present invention reduces the cost of treatments and eliminates the need for physician supervision during treatment. In accordance with that aspect, the composition of the present invention may be formed into a form suitable for topical administration including an amount of approximately 250 milligrams of Mucuna Pruriens extract containing approximately 20 percent L-dopa and approximately 125 milligrams of Tribulus L. Terrestris.

In another aspect, the composition of the present invention may be provided in a transdermal gel utilizing liposome technology to transport the homeopathic ingredients, herbs, and other nutrients directly through the skin for maximum absorption. This eliminates the need for high cost injections and also eliminates oral supplements which are quickly broken down in the digestive tract of the human.

In one embodiment, the composition of the present invention may include a liposome as the vesicle. As known by those having skill in the art, liposomes are highly complex microscopic lipidspheres, ranging in size from 50 nanometers to several micrometers in diameter, and formed when phospholipids are hydrated. The phosolipids join "tails to tails" to build a bilayer membrane which may enclose water in a phospholipidsphere. By this structure, liposomes can encapsulate water soluble ingredients in their inner waterspace, and oil soluble ingredients in their phospholipid membranes. Liposomes may be made with concentrated phospholipids purified from natural lechithin and may be bioidentical to the phospholipids that make up cell membranes. The liposome used in the present invention may be unilamellar or multilamellar. Thus in one embodiment, the liposome may be unilamellar and the first and said second ingredients may be located within an interior chamber. Alternatively, the liposome may be multilamellar and having first and second interior chambers. In this embodiment, one of the first and second ingredients may be located in the first interior chamber and the other of the first and second ingredients may be located in the second interior chamber. In yet another embodiment, the liposome may be multilamellar having first and second interior chambers, wherein one of the first and second ingredients is located in either the first or second interior chambers.

As described above, the vesicles for the gel or other substance for topical administration of the present invention include phospholipid membranes made of lipid components. More specifically, these vesicle-forming lipids may be an amphipathic lipid having a hydrophobic tail and a headgroup which conform spontaneously into bilayer vesicles in water. The vesicle-forming lipids are preferably ones having two hydrocarbon chains. These may be typically acyl chains, wherein the headgroup is either polar or nonpolar. As will be apparent to those having skill in the art, there are a variety of synthetic vesicle- forming lipids and naturally occurring vesicle-forming lipids suitable for use, such as phospholipids, which include, but are not limited to, phosphotidylcholine, phosphotidylethanolamine, phosphotidylserine, phosphotidylinositol, phosphotidic acid, and sphingomyelin. The two hydrocarbon chains may be approximately 14-22 carbon atoms in length, and have varying degrees of saturation. Such lipids may be obtained commercially or prepared according to methods well known by those of skill in

the art.

In addition to the vesicle-forming lipid component, the vesicles of the present invention can include other lipid components capable of being stably incorporated into lipid bilayers. These lipid bilayers have their hydrophobic moieties in contact with the interior, hydrophobic region of the bilayer membrane, and the polar headgroups oriented toward the exterior, polar surface of the membrane. For example, glycolipids, ceramides, and sterols, such as cholesterol, coprostanol, cholestanol, and cholestane, long-chain fatty acids, such as stearic acid, can be incorporated into the lipid bilayer. Other lipid components that may be used include fatty amines, fatty acylated proteins, fatty acylated peptides, oils, fatty alcohols, glyceride esters, petrolatum, and waxes. It will also be appreciated by those skilled in the art that a skin permeation enhancer may be included in lipid vesicle lipid components. In preparing the composition of the present invention into a vesicle, the hormone, or hormone potentiating substance, active ingredients, inactive ingredients, and any other components of the composition, may be entrapped in the central core compartment of the vesicles, between the lipid bilayers, in the interior of the lipid bilayers. Water soluble components may be entrapped in an interior compartment by adding those components to a water phase during preparation of an oil-in-water emulsion. The various ingredients of the composition, dissolved or suspended in the water phase, may be entrapped as part of the emulsion during lipid vesicle formation upon addition of the vesicle-forming lipids. Lypophilic ingredients may be added to an oil phase during preparation of the oil-in-water emulsion for entrapment in the interior compartment. Alternatively, lypophilic ingredients may be entrapped in the lipid bilayer by adding the ingredients to the vesicle-forming lipid and/or the other lipid components, such as cholesterol.

By the above-described method, a method of preparing a pharmacologically acceptable homeopathic composition for administration to a mammal, and to be delivered transdermally, may be prepared. This method includes providing a homeopathic hormone. In one embodiment, this hormone is testosterone. In another embodiment, this hormone is growth hormone. This hormone is combined with a plurality of active homeopathic ingredients. These active homeopathic ingredients may be liquified or, alternatively, may be solid. The combination of homeopathic hormone and active homeopathic ingredients may then be encased in liposomes by processes well known to those having skill in the relevant art and as described above. Once the composition has been prepared, it may be administered to a subject by applying the composition topically to a surface, such as a skin surface, of the subject. The composition is then absorbed transdermally through the skin to enter the human body, and thus increase levels of hormones within the human body. While the present invention has been illustrated by a description of various embodiments and while these embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, and representative composition and method shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general inventive concept. What is claimed is:

Claims

1. A pharmacologically acceptable composition for topical administration to a mammal, comprising: a first ingredient including a hormone; a second ingredient having a luteinizing agent for stimulating the production of a hormone by said body, said second ingredient being Eurycoma longifolia jack; and at least one vesicle operable for transporting said first ingredient from a first site external to a body to a second site internal to said body.

2. The composition of claim 1 , wherein said hormone is selected from the group consisting of testosterone and growth hormone.

3. The composition of claim 2, wherein said hormone is present in homeopathic form.

4. The composition of claim 3, wherein said homeopathic form is a dilution of said hormone to a potency selected from the group consisting of 10X, 30X, and 100X.

5. The composition of claim 2, wherein said hormone is testosterone and wherein said composition further comprises at least one estrogen blocker.

6. The composition of claim 5, wherein said estrogen blocker is selected from the group consisting of chrysin and diindolymethane.

7. The composition of claim 2, further including a plurality of active homeopathic ingredients.

8. The composition of claim 7, wherein the active homeopathic ingredients are selected from the group consisting of abrotanum, adrenalinum, alfalfa, anacardium orientale, arsenicum album, avena sativa, baryta carbonica, baryta iodata, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, ferrum metallicum, fucus vesiculosus, hekla lava, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidium, secale cornutum, silicea, and thuja occidentalis.

9. The composition of claim 2, wherein said hormone is testosterone and wherein said composition further includes somatropin.

10. The composition of claim 2, further including a plurality of inactive ingredients.

11. The composition of claim 10, wherein said inactive ingredients are selected from the group consisting of epimedium extract, aloe barbadensis extract, polyacrylamide, C13-14 isoparaffin, laureth 7, lecithin, saw palmetto extract, diazolidinyl urea, vitamin E acetate, sodium ascorbol phosphate, vitamin A, vitamin D3, and vitamin B2.

12. The composition of claim 1 , wherein said at least one vesicle is a liposome having an interior chamber.

13. The composition of claim 12, wherein said first ingredient is located within said interior chamber.

14. The composition of claim 12 wherein said liposome is formed from phospholipids selected from the group consisting of phosphotidylcholine, phosphotidylethanolamine, phosphotidylserine, phosphotidylinositol, phosphotidic acid, and sphingomyelin.

15. A pharmacologically acceptable composition for topical administration to a mammal, comprising: a first ingredient adapted to potentiate a hormone, said first ingredient being Eurycoma longifolia jack; and at least one vesicle operable for transporting said first ingredient from a first site external to a body to a second site internal to said body.

16. The composition of claim 15 wherein said first ingredient includes an herbal extract including an element for synthesizing a catecholamine.

1 . The composition of claim 16 wherein said element of said herbal extract is a hydroxylated amino acid.

18. The composition of claim 17 wherein said hydroxylated amino acid is L-

dopa.

19. The composition of claim 16 wherein said catecholamine to be synthesized is dopamine.

20. The composition of claim 18 wherein said herbal extract is of Mucuna Pruriens.

21. The composition of claim 15, wherein said first ingredient includes an herbal extract having an active component comprising a luteinizing agent.

22. The composition of claim 21 , wherein said herbal extract is Tribulus L. Terrestris.

23. The composition of claim 16, wherein said element for synthesizing a catecholamine is L-dopa, said L-dopa operable to stimulate said mammal to synthesize dopamine.

24. The composition of claim 23, further comprising a second ingredient operable to prevent L-dopa from degrading in a mammal, thereby enhancing dopamine uptake in the mammal.

25. The composition of claim 24, wherein said second ingredient is Tribulus L. Terrestris.

26. The composition of claim 16, wherein said hormone is selected from the group consisting of testosterone and growth hormone.

I

27. The composition of claim 26, wherein said hormone is testosterone and wherein said composition further comprises at least one estrogen blocker.

28. The composition of claim 27, wherein said estrogen blocker is selected from the group consisting of chrysin and diindolymethane.

29. The composition of claim 26, further including a plurality of active homeopathic ingredients.

30. The composition of claim 29, wherein the active homeopathic ingredients being selected from the group consisting of abrotanum, adrenalinum, alfalfa, anacardium orientale, arsenicum album, avena sativa, baryta carbonica, baryta iodata, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, ferrum metallicum, fucus vesiculosus, hekla lava, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidium, silicea, secale cornutum, and thuja occidentalis.

31. The composition of claim 26, wherein said hormone is testosterone and wherein said composition further includes somatropin.

32. The composition of claim 26, further including a plurality of inactive ingredients.

33. The composition of claim 32, wherein said inactive ingredients are selected from the group consisting of epimedium extract, aloe barbadensis extract, polyacrylamide, C13-14 isoparaffin, laureth 7, lecithin, saw palmetto extract, diazolidinyl urea, vitamin E acetate, sodium ascorbol phosphate, vitamin A, vitamin D3, and vitamin B2.

34. The composition of claim 16, wherein said at least one vesicle is a liposome having a first interior chamber.

35. The composition of claim 34, wherein said first homeopathic ingredient is located within said interior chamber.

36. The composition of claim 34, wherein said liposome is formed from phospholipids selected from the group consisting of phosphotidylcholine, phosphotidylethanolamine, phosphotidylserine, phosphotidylinositol, phosphotidic acid, and sphingomyelin.

37. A pharmacologically acceptable homeopathic composition for topical administration to a mammal consisting of: at least one non-hormone active homeopathic ingredient; and at least one vesicle operable for transporting said at least one non-hormone active homeopathic ingredient from a first site external to a body to a second site internal to said body.

38. The composition of claim 37, wherein said active homeopathic ingredient is selected form the group consisting of abrotanum, adrenalinum, alfalfa, anacardium orientale, arsenicum album, avena sativa, baryta carbonica, baryta iodata, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, ferrum metallicum, fucus vesiculosus, hekla lava, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidium, silicea, secale cornutum, and thuja occidentalis.

39. A pharmacologically acceptable homeopathic composition for topical administration to a mammal, consisting of: a first ingredient including an estrogen blocker; and at least one vesicle operable for transporting said first ingredient from a first site external to a body to a second site internal to said body.

40. The composition of claim 39, wherein said first ingredient is selected from the group consisting of chrysin and diindolymethane.

41. The composition of claim 40, further including a second ingredient having a luteinizing agent for stimulating the production of a hormone by said body.

42. The composition of claim 41 , wherein said second ingredient is Tribulus L. Terrestris.

43. A method of increasing hormone levels in a mammal, comprising: providing a composition comprising a first ingredient and at least one vesicle operable for transporting said first ingredient from a first site external to a body to a second site internal to said body, wherein said first ingredient includes Eurycoma longifolia jack; and transdermally administering said composition to a mammal by topical application.

44. The method of claim 43, wherein said hormone is selected from the group consisting of testosterone and growth hormone.

45. The method of claim 44, wherein said hormone is testosterone and wherein said composition further comprises at least one estrogen blocker.

46. The method of claim 45, wherein said estrogen blocker is selected from the group consisting of chrysin and diindolymethane.

47. The method of claim 43, wherein said composition further includes a plurality of active homeopathic ingredients.

48. The method of claim 47, wherein the active homeopathic ingredients are selected from the group consisting of abrotanum, adrenalinum, alfalfa, anacardium orientale, arsenicum album, avena sativa, baryta carbonica, baryta iodata, baryta muriatica, calcarea carbonica, calcarea fluorica, calcarea phosphorica, ferrum metallicum, fucus vesiculosus, hekla lava, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidium, secale cornutum, silicea, and thuja occidentalis.

49. The method of claim 44, wherein said hormone is testosterone and wherein said composition further includes somatropin.

50. The method of claim 44, wherein said composition further includes a plurality of inactive ingredients.

51. The method of claim 50, wherein said inactive ingredients are selected from the group consisting of epimedium extract, aloe barbadensis extract, polyacrylamide, C13-14 isoparaffin, laureth 7, lecithin, saw palmetto extract, diazolidinyl urea, vitamin E acetate, sodium ascorbol phosphate, vitamin A, vitamin D3, and vitamin B2.

52. The method of claim 43, wherein said at least one vesicle is a liposome having a first interior chamber.

53. The method of claim 52, wherein said first homeopathic ingredient is located within said interior chamber.

4. The method of claim 52, wherein said liposome is formed from phospholipids selected from the group consisting of phosphotidylcholine, phosphotidylethanolamine, phosphotidylserine, phosphotidylinositol, phosphotidic acid, and sphingomyelin.