Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2001-06-12
2003-07-15
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S874000
Reexamination Certificate
active
06593369
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to methods for enhancing female sexual desire and responsiveness. The present method also relates to compositions and kits useful for enhancing female sexual desire and responsiveness.
2. Discussion of the Background
The female sexual response cycle can be divided into the four following phases (as adapted from
Diagnostic and Statistical Manual IV
, “Sexual and Gender Identity Disorder,” American Psychiatric Association, Washington, D.C., pp. 493-494 and 735-751, 1994:
1. Desire, which includes fantasies about sexual activity and the desire to have sexual activity;
2. Excitement, which consists of subjective senses of sexual pleasure and accompanying physiological changes including vasocongestion in the pelvis, vaginal lubrication, and expansion and swelling of the external genitalia;
3. Orgasm, which consists of peaking of sexual pleasure with release of sexual tension; and
4. Resolution, which consists of a sense of muscular relaxation and general well-being.
Disorders of female sexual desire or response are estimated to affect from 30 to 50 percent of the adult population in various studies (see, e.g., S. G. Nathon, “The Epidemiology of the DSM-III Psychosexual Dysfunctions,”
J. of Sex and Marital Therapy
, vol. 12, no. 4, pp. 267-281 (1986);
Diagnostic and Statistical Manual IV
, “Sexual and Gender Identity Disorder,” American Psychiatric Association, Washington, D.C., pp.493-539, 1994; M. Osborn et al, “Sexual dysfunction among middle aged women in the community,”
British Medical Journal
, vol. 296, pp. 959-962 (1988); E. Frank et al, “Frequency of Sexual Dysfunction in “Normal Couples”,”
New England Journal of Medicine
, vol. 299, pp. 111-115 (1978); and K. Garde et al, “Female sexual behavior: a study in a random sample of forty-year-Old Danish Women,”
Maturitas
, vol. 2, pp. 225-240 (1980)). These very common disorders may have a variety of causes including psychogenic etiologies, anatomical disorders, drug-induced disorders, diabetes mellitus, post-surgical disorders, atherosclerosis, post-traumatic disorders, as well as endocrine etiologies.
The search for effective pharmacologic treatments to influence sexual behavior has been a preoccupation of all societies throughout history (see, e.g., E. L. Abel,
Psychoactive Drugs and Sex
, Plenum Press, New York, 1985; and J. Buffum, “Substance abuse and high-risk sexual behavior,”
J. Psychoact. Drugs
, vol. 20, pp.165-168 (1988)). In one of the few scientific review articles on this topic (R. C. Rosen et al, “Prosexual Drugs: Empirical Status of the “new Aphrodisiacs”,”
Archives of Sexual Behavior
, vol. 22(6), pp.521-543 (1993)), Rosen states: “In particular, the search for the perfect aphrodisiac—a drug that will heighten sexual desire, pleasure and performance has been a continuing cultural quest from ancient to modern times. Natural substances such as datura, belladonna and henbane were key ingredients in the sexual orgies of ancient fertility cults. Yohimbine has long been used by the natives of Africa to enhance their sexual prowess, as was the mandrake plant in medieval Europe (E. L. Abel,
Psychoactive Drugs and Sex
, Plenum Press, New York, 1985). Oysters, ginseng and Vitamin E have similarly been recommended at various times as possessing aphrodisiacal qualities (R. C. Rosen et al,
Sexuality
, Random House, New York, 1984). Given the perennial search for an effective aphrodisiac, it is surprising that relatively few drugs have been demonstrated to have specific prosexual properties.”
L-dopa has been reported to stimulate sexual responsiveness in male and female patients. However, subsequent studies have yielded inconsistent or contradictory results regarding the effect of L-dopa on sexual behavior (M. Hyppa et al, “Is L-dopa an aphrodisiac in patients with Parkinson's disease?,” in
Sexual Behavior Pharmacology and Biochemistry
, M. Sandler et al, Eds., Plenum Press, New York, 1975; and O. Benkert et al, “Effect of L-dopa on sexually impotent patients,”
Psychopharmacologia
, vol. 23, pp. 91-95 (1972)). Most of these studies deal exclusively with men and extremely few studies have even mentioned women. Apomorphine has been investigated for erectile dysfunction in men, but there have been no positive reports in women. Nomifensine and bupropion which are atypical anti-depressants acting on dopamine have been reported to have stimulatory effects on females with decreased sexual desire (S. Lal et al, “Apomorphine induced penile tumescence in impotence patients—preliminary findings,”
Prog. Neurol. Psychopharmacol. Biol. Psychiat.,
vol. 11, pp. 235-242 (1987). Subsequent studies by Klein et al did not replicate these effects (K. B. Klein et al, “Drug treatment of patients with inhibited sexual desire: A controlled clinical trial,” presented at the SSTAR annual meeting, New Orleans, 1987).
Prostaglandins may have a possible role in human ovulation (G. M. Craig, “Prostaglandins in reproductive physiology,”
PMJ
, vol. 51, pp. 74-84 (1975)). Prostaglandin E
1
(PGE-1), prostaglandin E
2
(PGE-2), and prostaglandin F
2&agr;
(PGF-2&agr;) cause uterine contraction in women. Indeed, PGE-2 is presently used in the United States for inducing labor and cervical ripening.
Present therapies for disorders of sexual response and desire include various types of psychotherapeutic counseling (J. LoPiccolo et al, “Treatment of Sexual Dysfunction,”
J. of Counseling and Clinical Psychology
, vol. 54(2), pp. 158-167 (1986)). There is also a report of using electrical stimulators placed inside the vagina to induce orgasms (see: D. Boutos, “Apparatus for stimulating penile, scrotal, anal, vaginal, and clitoral tissue,” U.S. Pat. No. 5,571,118). Neither of these methods are particularly desirable or effective in treating these disorders.
Thus, there remains a need for a method for enhancing female sexual desire and responsiveness. There also remains a need for pharmaceutical compositions and kits useful for enhancing female desire and responsiveness.
SUMMARY OF THE INVENTION
Accordingly, it is one object of the present invention to provide novel methods for enhancing female sexual desire and responsiveness.
It is another object of the present invention to provide novel pharmaceutical compositions which are useful for enhancing female sexual desire and responsiveness.
It is another object of the present invention to provide novel kits useful for enhancing female sexual desire and responsiveness.
These and other objects, which will become apparent during the following detailed description, have been achieved by the inventor's discovery that application of a prostaglandin directly to the clitoris of a female is effective for enhancing female sexual desire and responsiveness.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Thus, in a first embodiment, the present invention provides novel methods for enhancing female sexual desire and responsiveness. In the context of the present invention, the term enhancing female sexual desire and responsiveness includes the treatment of disorders of female sexual desire and/or response. The term disorders of female sexual desire and/or response means any disorder which causes a decrease in or absence of female sexual responsiveness or female sexual desire. This includes any persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity. It also includes decreases in the physiological response to sexual stimulation such as slowed or decreased erectile response of the female erectile tissues; slowed, decreased or absent lubrication of the vagina; slowed, decreased, or absent ability to have orgasms; decreased intensity of or pleasure in orgasms; frigidity; sexual aversion; and disorders of female sexual desire and response that are secondary to a general medical condition such as the menopausal or post-menopausal state, radiotherapy of the pelvis, atheroscelerosis, pelvic trauma or surgery, peripheral neuropathies, autonomic neuropathies, diabetes mellitus, and diso
Criares Theodore J.
Reed Dianne E.
Reed & Eberle LLP
Vivus Inc.
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