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![]() ![]() ![]() ![]() ![]() clinical trials : results introduction It has been estimated that up to 76% of women, depending upon their age, have complaints of sexual dysfunction, including decreased libido, vaginal dryness, pain with intercourse, decreased genital sensation and difficulty or inability to achieve orgasm. Female sexual dysfunction is a significant problem that affects the quality of life of many women. Vaginal relaxation can be an unwanted result of childbirth, aging or muscular de-conditioning. The muscles become relaxed and have poor tone, strength, and lack control. The internal and external diameters of the vagina increase. Under these circumstances, the vagina is no longer at its optimum physiological state. As a result, the sensual side of sexual gratification can become greatly diminished for both partners. The female sexual response cycle is initiated by neurotransmitter-mediated vascular and nonvascular smooth muscle relaxation resulting in increased pelvic blood flow, vaginal lubrication, and clitoral and labial engorgement. These mechanisms are mediated by a combination of neuromuscular and vaso-congestive events. Physiological impairments that interfere with the normal female sexual response bring about complaints associated with diminished sexual arousal, libido, vaginal lubrication, genital sensation, and ability to achieve orgasm. Clinical symptoms may include delayed vaginal engorgement, diminished vaginal lubrication, pain or discomfort with intercourse, diminished vaginal sensation, diminished vaginal orgasm, diminished clitoral sensation or diminished clitoral orgasm. Pelvic floor therapy with micro-stimulation of the vaginal musculature is used to promote perineal muscle strength. PK24 is the newest and most innovative non-surgical solution for vaginal tightening. PK24 is designed to renew, restore, and rejuvenate the interior walls of the vagina for up to 24 hours, thus increasing and restoring the physiological aspects of sexual gratification for both partners. The ingredients in PK24 plump and tighten the interior walls of the vagina. PK24 increases fullness, sensation and sexual pleasure for both partners. PK24 has been on the consumer market with no known reported side effects. study objectives No side effects reported and no adverse events reported related to the medication.
testing conclusion Vaginal smears did not show any increase of infection related to PK24 use. references Bancroft J. Sexual well being of women in heterosexual relationships: a national survey. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; page 17. Cain V, Johannes C, Mohr B, et al. Sexual practices among ethnically diverse midlife women. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; page 45 Meston C. Instruments designed to assess female sexual function. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; page 184. Derogatis L. The Derogatis interview for sexual functioning (DISF/DISF-SR): introductory report. J Sex Marital Ther. 1997;23:291-304. Rust J, Golombok S. The Golombok-Rust Inventory of Sexual Satisfaction. Odessa, Fla: Psychological Assessment Resources, Inc.; 1986. Clayton AH, McGarvey EL, Clavet GJ. The changes in sexual functioning questionnaire (CSFQ): development, reliability, and validity. Psychopharmacol Bull. 1997;33:731-745. Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI): Derogatis LR. Female sexual distress scale (FSDS): preliminary report. In: Female Sexual Function Forum: New Perspectives in The Management of Female Sexual Dysfunction. Boston University School of Medicine Continuing Medical Education, Department of Urology; October 2000; pp 175-180. Osborn M, Hawton K, Gath D. Sexual dysfunction among middle aged women in the community. BMJ. 1988;296:959-962. National Institute of Clinical Research, 1127 Wilshire Blvd, Suite 809, Los Angeles, CA 90017 |