Woodward, John R. (Dallas, TX, US)

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10/936965

03/09/2006

09/08/2004

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514/262.100

A61K31/519

Michael, O'neil A. P. C. (5949 SHERRY LANE, SUITE 820, DALLAS, TX, 75225, US)

1. A method of providing sexual enhancement in women comprising the steps of: identifying a woman desiring sexual enhancement; testing the blood of the identified woman to determine the amounts of free estradiol and free testosterone therein; assuring that the identified woman's blood includes free estradiol within a first predetermined range; assuring that the identified woman's blood includes free testosterone with a second predetermined range; thereafter administering to the identified woman a predetermined amount of a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS® (tadalfil).

2. The method of claim 1 wherein the identification step comprises a request from the woman to her physician for treatment to provide sexual enhancement.

3. The method according to claim 1 wherein the identification step includes a suggestion from the woman's physician that she will benefit from sexual enhancement.

4. The method according to clam 1 wherein the step of assuring that the woman's blood includes free estradiol within the first predetermined range includes the step of treating the woman to increase the percentage of free estradiol in her blood.

5. The method according to claim 1 wherein the step of assuring that the woman's blood includes free testosterone within the second predetermined range includes the step of treating the woman to increase the percentage of free testosterone therein.

6. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS® (tadalfil) is carried out by self administration.

7. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS®B (tadalfil) is carried out by administering a predetermined amount of LEVITRA® (vardenafil hydrochloride).

8. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS®D (tadalfil) is carried out by administering a predetermined amount of CIALIS® (tadalfil).

9. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS® (tadalfil) takes place at least one hour prior to sexual activity.

10. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS® (tadalfil) is carried out by self administration, and wherein the administration of the selected drug takes place at least one hour prior to sexual activity.

11. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS® (tadalfil) is carried out by administering a predetermined amount of LEVITRA® (vardenafil hydrochloride) at least one hour prior to sexual activity.

12. The method according to claim 1 wherein the step of administering a drug selected from the group consisting of LEVITRA® (vardenafil hydrochloride) and CIALIS® (tadalfil) is carried out by administering a predetermined amount of CIALIS® (tadalfil) at least one hour prior to sexual activity.

TECHNICAL FIELD

This invention relates generally to enhancement of sexual arousal and satisfaction in females, and more particularly to the use of drugs already approved for the treatment of erectile dysfunction in males to enhance sexual arousal and satisfaction in females.

BACKGROUND AND SUMMARY OF THE INVENTION

As is universally known, various drugs are now available for the treatment of erectile dysfunction. By stimulating the erectile process, these drugs promote sexual arousal and ultimately sexual satisfaction in men. The first drug of this type to gain widespread acceptance by Viagra® which introduced in 1998. Levitra® and Cialis® have been introduced more recently. Despite the fact that drug therapy which provides sexual enhancement in males has been available for at least fifteen years, corresponding sexual enhancement for women has not heretofore been available.

The present invention comprises a method of female sexual enhancement which overcomes the foregoing and other problems which have long since characterized the prior art. In accordance with the broader aspects of the invention, the same types of drugs that are utilized to treat erectile dysfunction in men are used to provide sexual enhancement in women. More particularly, it has been demonstrated with a drug selected from the group consisting of Levitra® and Cialis® prior to sexual activity results in significant enhancement of sexual arousal and sexual satisfaction in females.

More particularly, the initial step in the process of the present invention comprises identifying a woman desiring sexual enhancement. The process can be started either at the request of the woman herself, or at the suggestion of her physician. Thereafter, the woman's blood is tested to determine the presence of free estradiol and free testosterone. If the woman's blood contains estradiol within a first predetermined range and free testosterone within a second predetermined range the process of the present invention continues. If not, the woman is treated utilizing conventional techniques to bring the level of free estradiol in her blood to within the first predetermined range and/or to bring the level of free testosterone in her blood to within the second predetermined range.

After the required amount of free estradiol and the required amount of free testosterone in the woman's blood has been assured, the woman is treated with a drug selected from the group consisting of Levitra® and Cialis®. In most instances the drug is self-administered by the woman desiring sexual enhancement. The typical dosage is k of the recommended dosage of the same drug for the treatment of erectile dysfunction in males. The selected drug is preferably administered at least one hour before sexual activity.

The use of the drug Viagra® to achieve sexual enhancement in women has heretofore been attempted. The use of Viagra® for such purposes has been found to be unsatisfactory because of unacceptable side affects. The unacceptable side affects that are observed in women using Viagra® for sexual enhancement include:

• • Headaches
  • Facial flushing
  • Nasal congestion
  • Indigestion
  • Bluish tinge to vision lasting up to a few hours.
    Due to the foregoing side affects, it has been determined that Viagra® cannot be successfully utilized for sexual enhancement in women.

BRIEF DESCRIPTION OF THE DRAWING

A more complete understanding of the present invention may be had by reference to the following Detailed Description when taken in connection with the accompanying Drawing, wherein:

FIG. 1 is a flowchart illustrating the method of the present invention.

DETAILED DESCRIPTION

Referring to the Drawing, the first step in the practice of the method of the present invention comprises the identification of a woman desiring sexual enhancement. Typically this step occurs as part of a consultation between the woman and her physician. The consultation may be specially scheduled in order that the woman may avail herself of the present invention. More often, however, the identification step occurs during a meeting of the woman with her physician for other purposes, such as a regularly scheduled consultation, an examination unrelated to the present invention, a procedure, etc. The woman may be identified as a participant in the method of the present invention either at her own request or at the suggestion of her physician.

After her identification as a participant in the method of the present invention the woman's blood is tested for the presence of free estradiol and free testosterone therein. The successful practice of the method of the present invention requires that the woman's blood contains free estradiol within a first predetermined range and free testosterone within a second predetermined range. For example, one laboratory has established the first predetermined range as between about 0.5 picograms and about 1.5 picograms of free estradiol per 1 cc of blood serum, and has established the second predetermined range as between about 2.2 picograms and about 7.2 picograms of free testosterone per 1 cc of blood serum. Other laboratories have similar, but not necessarily identical definitions of the first and second predetermined ranges.

If the blood test reveals that the amount of free estradiol in the woman's blood is below the first predetermined range the amount of free estradiol in the woman's blood is raised utilizing conventional practices and procedures. For example, non-oral, bio-identical estradiol administered as a transdermal cream, as a patch, as a sub-cutaneous pellet. Similarly, if the blood test reveals that the amount of free testosterone in the woman's blood is below the second predetermined range, conventional practices and procedures are undertaken for the purpose of raising the amount of free testosterone in the woman's blood. For example, non-oral, bio-identical testosterone administered as a transdermal cream, as a patch, or as a sub-cutaneous pellet. In some instances it may be necessary to raise both the amount of free estradiol and the amount of free testosterone in the woman's blood.

After the required level of free estradiol and free testosterone in the woman's blood have either been confirmed or established, a drug selected from the group consisting of Levitra® and Cialis® is administered to the woman prior to sexual activity. In most instances the selected drug is self-administered. It has been determined that the selected drug should be administered at least one hour prior to the beginning of sexual activity. The optimum time interval between administration of the selected drug and the beginning of sexual activity may vary depending on the particular circumstances and is best determined by the woman through experimentation. It has also been determined that the appropriate dosage a drug selected from the group consisting of Levitra® and Cialis® in order to enhanced sexual stimulation and satisfaction is one half of the dosage of the same drug that is recommended for administration to males to treat erectile dysfunction. The exact amount of the drug that is appropriate for a particular woman may vary depending upon a variety of circumstances all of which are best explored through consultation between the woman and her physician.

It has been determined that the method of the present invention results in substantial sexual enhancement in women, including in particular substantially improved sexual arousal and substantially improved sexual satisfaction. This in turn results in an improved overall feeling of wellness, an improved sexual relationship between the woman and her partner, and an overall improvement in self esteem.

Although preferred embodiments of the invention have been illustrated in the accompanying Drawings and described in the foregoing Detailed Description, it will be understood that the invention is not limited to the embodiments disclosed, but is capable of numerous rearrangements, modifications, and substitutions of parts and elements without departing from the spirit of the invention.