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Methods and compositions for treating erectile dysfunctionRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Effervescent Or Pressurized Fluid Containing, Organic Pressurized Fluid, Powder Or Dust ContainingMethods and compositions for treating erectile dysfunction description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20080095718, Methods and compositions for treating erectile dysfunction. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCES [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/813,100 filed on Mar. 19, 2001, to be issued as U.S. Pat. No. 6,632,419 which is a continuation-in-part of U.S. patent application Ser. No. 09/563,773 filed on May 2, 2000, now issued U.S. Pat. No. 6,428,769 and claims the benefit of U.S. Provisional Patent Application Ser. No. 60/132,472 filed on May 4, 1999, all of which are incorporated herein by reference in their entirety. FIELD OF THE INVENTION [0002] This invention relates generally to methods of treating sexual dysfunction in humans. Such methods include treating women with a decreased libido, treating men with reduced libido and/or having a decreased level of serum testosterone, and treating men having erectile dysfunction. More specifically, the invention relates to acute, bolus non-invasive administration of testosterone to enhance libido and/or a drug formulation to treat erectile dysfunction over a discrete period of time. BACKGROUND OF THE INVENTION [0003] The presence of a normal amount of libido, defined as the urge to engage in sexual activity, is an important component of an individual's well-being. In both men and women the primary naturally occurring hormone responsible for libido is testosterone. In males, the baseline testosterone level is a relatively constant throughout life, decreasing slowly in old age. Abnormally low levels of testosterone also occur in male hypogonadism and are similarly associated with lack of libido and inability to produce or sustain erections. In contrast, women elaborate testosterone only as part of the process of ovulation. Each maturing follicle produces testosterone at the mid-point of the menstrual cycle, consistent with observations that female libido peaks with ovulation. As a woman ages, the number of maturing follicles per month decreases, and there is a decreasing total amount of testosterone produced. A common complaint of post-menopausal women is decreased libido. This decrease in libido is characterized by a lack of interest in sexual intercourse, the lack of ability to achieve orgasm, or decrease in intensity of orgasm. It is important to note that this decrease in libido is often associated with a profound sense of loss of a once normal and active interest in sexual activity. Low levels of testosterone in, e.g., hypogonadal men are associated with lack of libido and absence of erections. They respond to therapy with exogenous testosterone (Cunningham et al., J Clin Endocrinol Metab, (March 1990) 70:792-7; Behre et al., J Clin Endocrinol Metab, (November 1992) 75:1204-10; and women also respond to testosterone therapy, see Tuiten et al., Arch. Gen. Phychiatry, (February 2000) 57:149-153. [0004] Clinicians frequently confronted with the problem of managing female patients presenting with decreased libido have limited tools to address the problem. Testosterone is available as an oral preparation and can be given, for instance, in combination with estrogen to restore testosterone levels. However, the replacement of the once pulsatile endogenous delivery of testosterone with the sustained blood level of the hormone produces unwanted side effects. Women taking testosterone for a few weeks typically begin to complain of the emergence of secondary sexual characteristics such as unwanted body hair, oily hair, and, with prolonged a use, deepening voice. For this reason, oral testosterone replacement therapy is not a practical solution for most patients with decreased libido. [0005] Other forms of testosterone replacement therapy for women are being explored. A transdermal patch capable of delivering a steady rate of testosterone is being tested for use in women. As with oral testosterone replacement therapy, the study state blood levels of testosterone produced via transdermal delivery are likely to be associated with the same side effect profile issues. [0006] It is recognized that testosterone in males and females decreases with age (Expert Opin. Pharmacother 2003 February; 4(2):183-90; Human Biology, May 1980, Vol. 52, No. 2, pages 181-0191), and that sexual motivation in men with low testosterone as well as mood and well-being in post-menopausal women is associated with the levels of exogenously introduced testosterone (Psychosomatic Medicine volume 47, No. 4, 1985). Further, providing intravenous testosterone to men and women as part of clinical studies is known (Am Heart J 2002 February; 143(2):249-56; American Journal of Obstetrics and Gynecology, December 1986 pages 1288 to 1292). [0007] Various formulations of testosterone are currently commercially available to treat sexual dysfunction in men. A transdermal patch for men is sold by Alza Corporation under the name of Testoderm.RTM.. An injectable for intramuscular injectable is sold by Bristol-Meyers Squibb Company under the name Delatestryl.RTM., and by Star under the name Virilon.RTM. IM. While these dosage forms may increase steady state levels of testosterone in men, they do not result in the physiologically correct pulsatile release that occurs in men with normal testosterone production. A bolus delivery of testosterone provides an approximation to the pulsatile delivery yielding short brief peaks that can provide the physiological stimulus for increase of sexual desire and improved erectile function. [0008] Current therapies and those under development for erectile dysfunction (ED) include phosphodiesterase (PDE) inhibitors (e.g., Viagra (sildenafil), Clalis), dopamine receptor agonists (e.g., apomorphine), melanocortin receptor agonists, intracavernous therapies (e.g., alprostadil, papaverine, phentolamine, vasoactive intestinal peptide), growth hormone-releasing peptide receptor agonists, 5-hydroxytryptamine (5-HT; serotonin) receptor agonists, alpha-adrenoceptor antagonists, topical therapies (e.g., alprostadil), guanylyl cyclase activators, rho-kinase antagonists and inhibitors of neuropeptide Y. [0009] In cases where a single therapy for ED is ineffective, combination therapy may be effective, especially when two or more mechanisms the drugs affect different sites of action are simultaneously employed. For example, the combination of a drug that acts centrally, e.g., on the central nervous system (CNS), with a drug that acts peripherally has been proposed (Andersson and Hedlund, Int. J. Impot. Res. 14(Supp1.1): S82-S92, 2002). For example in a rat model, the erectile response to apomorphine, which acts via the CNS, has been prolonged by sildenafil, which acts peripherally (Andersson et al, J. Urol. 161: 1707-12, 1999). The use of a combination therapy involving inhaled testosterone, which acts on the CNS, with any other class of treatment, whether it acts centrally or peripherally, having therapeutic potential may be more effective than either treatment alone. SUMMARY OF THE INVENTION [0010] The present invention provides for various methods of treating sexual dysfunction in humans, including reduced libido in women, reduced libido in men, and erectile dysfunction in men. [0011] In one embodiment, a method is provided for increasing the libido of a woman over a discrete period of time (e.g., 30-240 minutes) by the administration of testosterone. This method does not maintain therapeutic levels of testosterone over long periods, e.g., days, weeks or months. Because the method of the invention only maintains therapeutic levels over a short period, the adverse side effects of long-term testosterone treatment are avoided. [0012] In another embodiment, a method is provided for increasing libido and/or treating erectile dysfunction in a man by the administration of testosterone or another drug formulation including, but not limited to, sildenafil, including sildenafil citrate and other salts of sildenafil as well as other drug formulations and combinations of testosterone, sildenafil, and/or other drugs. [0013] The testosterone formulation used with the present invention may be comprised of a reduced version of testosterone having been reduced by 5.alpha.-reductase to 5.gamma.-dihydroxytestosterone which is delivered in a bolus dose. The testosterone formulation may be administered in a variety of different ways, e.g., may be aerosolized preferably producing particles which have a size in a range of from about 1 to 3 microns which can be inhaled into areas of the lung where they can readily enter the blood stream. [0014] With the methods of the present inventions, an aerosol containing a drug is inhaled into the lungs of a patient. Once inhaled, particles of the drug deposit on lung tissue and from there enter the patient's circulatory system and thereby increase the patient's serum testosterone level. In certain embodiments, the aerosol comprises testosterone or its reduced version 5-.gamma.-dihydrotestorone. The percentage increase in the patient's testosterone level will vary depending on the needs of the patient. However, the patient's normal baseline serum testosterone level is preferably increased 25% or more and more preferably 100% or more. By preferably providing the testosterone in a reduced form, i.e., 5.alpha.-dihydroxytestosterone because the delivery is by inhalation the patient's serum level of an active form of the hormone is quickly raised to a desired level, e.g., in thirty minutes or less, more preferably fifteen minutes or less. When the patient's blood serum level of the active form of the hormone is raised to a desired level the patient's libido is increased. The increased level gradually subsides (as the hormone is metabolized and cleared) thereby avoiding the adverse side effects generated by maintaining enhanced hormone levels over long periods. Where the aerosol comprises a drug for treating erectile dysfunction, the effect of the drug is realized in less time than when delivered by other routes of administration such as oral, and preferably is realized in less than 30 minutes, more preferably in less then 20 minutes, still more preferably in less than 10 minutes. [0015] An aspect of the invention is a method of increasing the libido of an adult human female patient by the administration of a bolus dose of testosterone which quickly increases the level of testosterone in the patient for a relatively brief time. [0016] Another aspect of the invention is a method of treatment whereby testosterone or derivative thereof is aerosolized, inhaled and provided to the circulatory system of the patient at levels sufficient to increase libido (over a short period of time) and propensity for orgasm. [0017] Another aspect of the invention is to combine bolus delivery of testosterone with additional treatment such as a topical cream applied to the vaginal area to increase blood flow to that area. [0018] An advantage of the invention is that the testosterone levels are raised within minutes of administration (preferably 30 minutes or less) and return to normal levels within hours--preferably in less than four hours. [0019] Another advantage is that the administered testosterone is quickly metabolized allowing the patient's testosterone levels to return to normal thereby avoiding the adverse effects of long-term administration. [0020] Another advantage of the invention is that erectile dysfunction and sexual dysfunction are treated more rapidly, as compared to other delivery routes, e.g., orally or transdermally, due to the rapid absorption of small molecules through the lung when inhaled, in order that the user need not plan ahead before engaging in sexual activity Continue reading about Methods and compositions for treating erectile dysfunction... Full patent description for Methods and compositions for treating erectile dysfunction Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Methods and compositions for treating erectile dysfunction patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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