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Title:
COMPOSITION AND METHOD FOR IMPROVING SEXUAL DESIRE AND ERECTILE FUNCTION
Document Type and Number:
WIPO Patent Application WO/2003/030887
Kind Code:
A1
Abstract:
A composition and method for improving sexual desire and erectile function is disclosed in which a sufferer is administered orally a natural composition containing Androstenedione, 4-Androstenediol, Zinc monomethionine, Magnesium aspartate, B-6, lycopene, lecithin, serenoa repens and epimedium sagittatum in an effective amoutn.

Inventors:
HAYGOOD DON PERRY (US)
Application Number:
PCT/US2001/031447
Publication Date:
April 17, 2003
Filing Date:
October 09, 2001
Export Citation:
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Assignee:
HERTURN L L C (US)
HAYGOOD DON PERRY (US)
International Classes:
A61K31/01; A61K31/198; A61K31/4415; A61K31/568; A61K31/5685; A61K31/685; A61K36/296; A61K36/889; (IPC1-7): A61K31/01; A61K31/198; A61K31/4415; A61K31/568; A61K31/5685; A61K31/685; A61K35/78
Other References:
DATABASE ADISALERTS [online] FIET ET AL.: "Differential changes in hormonal and sexual status in BPH patients treated by uncompetitive (permixon) or competitive (proscar) 5-alpha-reductase inhibitors", XP002907023, accession no. STN Database accession no. 2000:10709
Attorney, Agent or Firm:
Novatt, Janine Rickman (AZ, US)
Download PDF:
Claims:
CLAIMS 1 CLAIM
1. A composition for improving sexual desire and erectile function comprising in the range of 4065 mg Androstenedione, 2045 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, 80125 mg Magnesium Aspartate, 2045 mg B6 (pyrodoxide HCI), 1050 mg Lycopene, 60125 mg Lecithin, 75150 mg Serenoa Repens, and 75200 mg Epimedium Sagittatum.
2. The composition of Claim 1, comprising about 50 mg Androstenedioine, about 25 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, about 100 mg Magnesium Aspartate, about 25 mg B6 (pyrodoxide HCI), about 15 mg Lycopene, about 100 mg Lecithin, about 100 mg Serenoa Repens, and about 100 mg Epimedium Sagittatum.
3. The composition of Claim 1, consisting essentially of about 50 mg Androstenedione, about 25 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, about 100 mg Magnesium Aspartate, about 25 mg B6 (pyrodoxide HC1), about 15 mg Lycopene, about 100 mg Lecithin, about 100 mg Serenoa Repens, and about 100 mg Epimedium Sagittatum.
4. A composition comprising an effective amount to substantially improve sexual desire and erectile function of each of : Androstenedione, 4Androstenediol, Zinc Monomethionine aspartate, Magnesium Aspartate, B6 (pyrodoxide HC1), Lycopene, Lecithin, Serenoa Repens, and Epimedium Sagittatum.
5. The composition of Claim 4, comprising in the range of 4065 mg Androstenedione, 2045 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, 80125 mg Magnesium Aspartate, 2045 mg B6 (pyrodoxide HC1), 1050 mg Lycopene, 60125 mg Lecithin, 75150 mg Serenoa Repens, and 75200 mg Epimedium Sagittatum.
6. The composition of Claim 4, comprising about 50 mg Androstenedioine, about 25 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, about 100 mg Magnesium Aspartate, about 25 mg B6 (pyrodoxide HC1), about 15 mg Lycopene, about 100 mg Lecithin, about 100 mg Serenoa Repens, and about 100 mg Epimedium Sagittatum.
7. The composition of Claim 4, consisting essentially of about 50 mg Androstenedione, about 25 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, about 100 mg Magnesium Aspartate, about 25 mg B6 (pyrodoxide HCI), about 15 mg Lycopene, about 100 mg Lecithin, about 100 mg Serenoa Repens, and about 100 mg Epimedium Sagittatum.
8. A method of improving sexual desire and erectile function comprising the steps of administering to a subject suffering from no or low sexual desire or erectile dysfunction, a composition comprising Androstenedione, 4Androstenediol, Zinc Monomethionine aspartate, Magnesium Aspartate, B6 (pyrodoxide HC1), Lycopene, Lecithin, Serenoa Repens, and Epimedium Sagittatum each in an effective amount for improving sexual desire and erectile function.
9. The method of Claim 8, wherein said composition comprises in the range of 4065 mg Androstenedione, 2045 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, 80125 mg Magnesium Aspartate, 2045 mg B6 (pyrodoxide HCI), 1050 mg Lycopene, 60125 mg Lecithin, 75150 mg Serenoa Repens, and 75200 mg Epimedium Sagittatum.
10. The method of Claim 8, wherein said composition comprises about 50 mg Androstenedioine, about 25 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, about 100 mg Magnesium Aspartate, about 25 mg B6 (pyrodoxide HC1), about 15 mg Lycopene, about 100 mg Lecithin, about 100 mg Serenoa Repens, and about 100 mg Epimedium Sagittatum.
11. The method of Claim 8, wherein said composition consists essentially of about 50 mg Androstenedione, about 25 mg 4Androstenediol, 15 mg Zinc Monomethionine aspartate, about 100 mg Magnesium Aspartate, about 25 mg B6 (pyrodoxide HCI), about 15 mg Lycopene, about 100 mg Lecithin, about 100 mg Serenoa Repens, and about 100 mg Epimedium Sagittatum.
12. The method of Claim 8, wherein said composition is administered orally.
13. The method of Claim 8, wherein said composition may be administered in addition to VIAGRAO.
Description:
COMPOSITION AND METHOD FOR IMPROVING SEXUAL DESIRE AND ERECTILE FUNCTION FIELD OF THE INVENTION This invention relates generally to sexual enhancers. More specifically, this invention relates to a composition and method for improving sexual desire and erectile function.

BACKGROUND OF THE INVENTION Male erectile dysfunction (ED) (also called impotence) is the inability for a sexually active male to obtain and sustain an erection for sexual purposes. Symptoms may also include loss of sexual desire, premature ejaculation, or inability to achieve orgasm. About 30 million men in the United States alone suffer from some degree of ED.

Erectile dysfunction can have physical, psychological or drug-induced causes.

Most researchers and doctors now believe that physical factors are responsible for the majority of erectile dysfunction cases. Erections are caused by an increase in blood flow into the small arteries of the penis. Dilation of blood vessels necessary for a normal erection depends on a substance called nitric oxide, and nitric oxide formation depends on the amino acid arginine. Impotence can be a sign of a more serious health condition. Restriction of blood flow is the actual cause of impotence. Several health conditions cause this restriction of blood flow throughout the body. Cardiovascular conditions and poorly controlled diabetes can cause circulatory problems that may lead to erectile problems. Hormonal imbalances may also cause erectile dysfunction.

The two most single causes of ED are vascular disease and diabetes. The majority of men with ED suffer from these and other physical causes, including hormone

disorders, high blood pressure, spinal cord injuries, multiple sclerosis, prostate or pelvic surgery, heart problems, venous leaks from the penis, certain medication use and substance/alcohol abuse. Smoking doubles the probability of ED when combined with another risk factor, and is itself a cause of blood flow problems. In some cases, ED has a psychological foundation such as depression or anxiety. Sometimes ED is simply a manifestation of a relationship problem.

Men can also experience low libido, or sex drive, with or without erectile problems. This loss of sexual drive may be related to"male menopause", illness, stress, depression, excessive use of drugs and/or alcohol, and certain prescription medications. What defines a low libido for an individual is subjective and depends upon many variables. Physical and mental health are key factors and sex drive may decrease with age. While any illness can decrease sex drive, some conditions, such as thyroid disease, tumors of the pituitary gland (which controls most hormone production, including sex hormones), and depression, are directly linked to low libido. Similarly insufficient amounts of the male sex hormone testosterone may cause low libido, though such a condition is unlikely to affect erectile function. Drugs and stress can also decrease libido.

Sexual potency is related to feelings of power, competence, self-confidence and a healthy sense of narcissim. When sexual potency begins to wane, the man may feel that he is losing control of himself, of his mind, his body, and of being able to influence his world. These feelings can lead to anxiety, depression and an inability to function in the world from an interpersonal, business and professional level. When this happens, the man and usually the people in his life suffer.

Depending on the cause, conventional therapy may include psychological and behavioral counseling, treatment of underlying cardiovascular disease and avoidance of certain medications (such as cimetidine, antihypertensives and MAO inhibitors).

Drug treatments for ED include male hormone replacement therapy (testoterone, DHEA), sildenafil citrate (VIAGRA@), and medications inserted or injected into the penis (alprostadil). The herbs yohimbe and yohimbine (the primary active constituent in yohimbe) have also been found to be helpful. Viagra0, the most well-known impotency treatment only works in approximately 82% of men who use it. Moreover, as it is a prescription medication, an office visit to a health care provider is required increasing the costs and embarrassing some ED sufferers. Moreover, VIAGRAO is not recommended for men on nitrate medication for heart disease or suffering from the rare eye disease retinitis pigmentosa. As with all drugs, side effects may occur and the cost of these drugs is significant, especially when one considers the added cost of the required office visit. Moreover, VIAGRAO is only recommended to be taken once a day about one hour before engaging in sexual activity thus effectively limiting sexual activity to once per day. For most patients, the effect of VIAGRAO begins about 30 minutes after it is taken and lasts up to four hours. Penile vacuum devices and surgical procedures, such as penile implants and vascular repair, are usually limited to those who have not responded to other treatments. None the current options have been entirely successful in improving sexual desire or erectile function.

Accordingly, there has been a need for another weapon in the armamentarium against ED and against no or low sexual desire. There is an additional need for a composition and method to achieve optimum or ultimate sexual vitality. There also exists a need for a composition and method of improving sexual desire and erectile

function that are natural, convenient, non-toxic, and can be obtained without embarrassment, a prescription, or the cost of an office visit. There has also been a need for a novel composition and method that are safe and effective to use on a routine basis rather than just prior to or during sexual activity. There is a still further need for a composition and method that are less intrusive and permitting more spontaneity than conventional therapies with the possibility of repeated sexual activity not limited to once per day as with some conventional therapies. There is an additional need for a composition and method that may be used in addition to conventional therapies to improve sexual vitality overall. The present invention fulfills these needs and provides other related advantages.

SUMMARY OF THE INVENTION The present invention relates to a natural composition and method of improving sexual desire and erectile function by oral administration of a dietary supplement composition comprising about: 40-65 mg Androstenedione 20-45 mg 4-Androstenediol 15 mg or less Zinc Monomethionine Aspartate 80-125 mg Magnesium Aspartate 20-45 mg Vitamin B-6 (pyridoxide HCL 82%) 0-50 mg Lycopene 1% 60-125 mg Lecithin 75-150 mg Serenoa Repens 75-200 mg Epimedium Sagittatum In a preferred form of the invention, the composition comprises about: 50 mg Androstenedione 25 mg 4-Androstenediol 15 mg Zinc Monomethionine Aspartate 100 mg Magnesium Aspartate 25 mg B-6 (pyrodoxide Hcl) 15 mg Lycopene 100 mg Lecithin

100 mg Serenoa Repens 100 mg Epimedium Sagittatum The method of the invention comprises administering the composition orally two times per day on a routine daily regimen.

Other features and advantages of the present invention will become apparent from the following more detailed description.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention is concerned with a composition and method for improving sexual desire and erectile function and overall sexual vitatlily. The composition comprises in each dose in a 00 gel capsule, generally about: 40-65 mg Androstenedione 20-45 mg 4 Androstenediol 15 mg or less Zinc Monomethionine Aspartate 80-125 mg Magnesium Aspartate 20-45 mg Vitamin B-6 (pyridoxide HCL 82%) 0-50 mg Lycopene 1% 60-125 mg Lecithin 80-150 mg Serenoa Repens 75-200 mg Epimedium Sagittatum (horny Goat Weed) In a preferred form of the invention, the composition in each capsule comprises about: 50 mg Androstenedione 100% Pharmaceutical Grade 25 mg 4-Androstenediol 100% Pharmaceutical Grade 15 mg Zinc Monomethionine 15 mg Elemental Zinc 100 mg Magnesium Aspartate 20% Elemental Magnesium 25 mg B-6 (pyrodoxide HCL) 82% material 15 mg Lycopene 1 % material 100 mg Lecithin 100% material 100 mg Serenoa Repens Standardized to 85%-95% fatty acids and stearols 100 mg Epimedium Sagittatum Standardized 10% Icariin

These amounts substantially ensure maximum effect. Through investigation and research, the particular range of components, and in particular these optimal amounts within the ranges, have been found to substantially improve sexual desire and erectile function. Fillers such as maltodextrin, magnesium stearate, and other known flow agents may be added to substantially prevent the composition from clumping.

The composition is manufactured according to good manufacturing practices (GMPs) recommended by the National Nutritional Foods Association. In order to make-"00"capsules each containing the preferred form of the invention, the following batch weights are provided: 270, 000 Capsules 540, 000 Capsules Androstenedione 13.5 Kg (6.1236 Lbs) 27Kg (12.2472 Lbs.)<BR> 4-Androstenediol 6.75Kg (3.0618 Lbs. ) 13. 5Kg (6.1236<BR> Lbs.)<BR> Zinc Monomethionine Aspartate 4 05Kg (1.837 Lbs. ) 8. 1Kg (3.674<BR> Lbs.)<BR> Magnesium Aspartate 27Kg (12.25 Lbs. ) 54Kg (24.5 Lbs. )<BR> B-6 (pyridoxide HCI) 6.75Kg (3.0618 Lbs. ) 13. 5Kg (6.1236<BR> Lbs.)<BR> Lycopene 4. 05Kg (1.837 Lbs. ) 8. 1Kg (3.674<BR> Lbs.)<BR> Lecithin 27Kg (12.25 Lbs. ) 54Kg (24.5 Lbs. )<BR> Serenoa Repens 27Kg (12.25 Lbs. ) 54Kg (24.5 Lbs. )<BR> Epimedium Sagittatum. 27Kg (12.25 Lbs) 54Kg (24.5 Lbs. )<BR> Total Weight For Batch of 270,000 Capsules-143. 1K (64.9212 Lbs. ) Total Weight For Batch of 540,000 Capsules-286.2K (129.8424 Lbs).

Each raw material component is subjected to an identity test (typically thin layer chromatography) and scaled up individually and upon completion of that task,

all materials are transferred to a planetary blender (capacity approximately 500 Kilograms) to blend all components. The blending process lasts for approximately 1 hour at room temperature at which time the ingredients are removed and taken to an encapsulation room for encapsulation.

The raw materials are available from such suppliers as Sabinsa Corp. , 121 Ethel Road West, Unit 6, Piscataway, N. J. 08854, Seltzer Chemicals, 5927 Geiger <BR> <BR> Court, Carlsbad, CA 92008, and AIDP Inc. , 1120 Coiner Court, City of Industry, CA 91748.

In the method of the invention, the composition is administered orally, preferable in gelatin capsules. The suggested dose schedule is one capsule two times per day, morning and evening, or as directed by a health care professional. The composition may of course be incorporated in other delivery methods, such as tablets, etc. by methods known to persons skilled in the art. The composition may be administered with VIAGRA@ if permitted by a health care professional.

Preliminary studies on the toxicity of the composition on rats showed no toxicity when administered orally over a period of twelve weeks.

Preliminary observation in several men confirms the usefulness of the composition in increasing sexual desire and erectile function. For example, several men complained that age had caused them to lose sexual desire and the ability to have an erection. After taking the composition on a routine basis for eight weeks, these men reported enhanced sex drive and stability, sharpened sexual reflexes overall, improved energy and a sense of well-being. Other men found that there was more sexual desire, more energy and no side effects.

From the foregoing, it is to be appreciated that the composition and method is effective in improving sexual desire and erectile function to increase sexual vitality and the male's sense of well-being and to improve sexual performance. The use of the composition may be substantially less expensive, less intrusive, and less toxic than some of the currently available treatments.

Although a particular embodiment of the invention has been described in detail for purposes of illustration, various modifications may be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to be limited, except as by the appended claims.