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Zestra for Women is a botanical feminine massage oil formulated to enhance female sexual pleasure and arousal when applied to the vulva. We conducted this randomized, double-blinded, crossover study to evaluate the efficacy and safety of Zestra for Women compared to placebo oil in 10 women with and 10 women without female sexual arousal disorder (FSAD) in conditions of home use it, conjunction with sexual activities. Subjects were screened by physical examination, sex therapist interviews, and questionnaires. We randomized qualified subjects to treatment paths and gave them 5 doses of test article and diaries to use at home. At Visit 2, we assessed them by questionnaires and gave them 5 doses of crossover test article and diaries to use at home. At the final visit, we assessed then, with questionnaires. We assessed safety by adverse event reports and primary efficacy by responses to a diary question regarding satisfaction with arousal. Secondary efficacy instruments included remaining diary questions, recall-based questionnaires. global assessment questions, and a consumer-testing questionnaire. All 20 subjects completed the study. Three subjects reported single incidences of mild genital burning sensations lasting 5--30 rain after use of Zestra for Women. Both normal and FSAD women showed statistically significant improvements, relative to placebo, in level of arousal, level of desire, satisfaction with arousal, genital sensation, ability to have orgasms, and sexual pleasure. Although FSAD women showed greater magnitude of response, the presence of FSAD had no effect on response rates. Zestra for Women was just as effective in women using selective serotonin reuptake inhibitor antidepressants as in women not using antidepressants. Zestra for Women improved sexual function in normal and FSAD women under conditions of home use. [ABSTRACT FROM AUTHOR]

Abstract: There is a slow but continuous decline in testosterone (T) levels with age, with a substantial percentage of males exhibiting T levels in the hypogonadal range. This age-dependent decline in circulating androgens is associated, in large part, with reduced sexual functioning and libido. The effectiveness of Testim® 1% (Auxilium Pharmaceuticals, Inc., Norristown, Pennsylvania) topical T gel was evaluated in older hypogonadal males who failed to experience satisfactory symptom relief after treatment with AndroGel® 1% (Solvay Pharmaceuticals, Inc., Marietta, Georgia). In this open-label study, consecutive subjects were assigned randomly to experimental treatment with Testim 1% (5 g) or to maintenance therapy (control group) with AndroGel 1% (5 g). Seventy-six experimental subjects and 75 control subjects were followed for 4 weeks to evaluate improvements in sexual functioning and satisfaction. Changes from baseline in the 5 domains of the Brief Male Sexual Function Inventory were compared between groups. The mean percentage improvement favored the experimental treatment in sexual drive (23% vs 16%, P < 0.3), erectile function (32% vs 8%, P < 0.03), ejaculatory function (11% vs 9%, P < 0.4), problem assessment (47% vs 12%, P < 0.01), and sexual satisfaction (62% vs 23%, P < 0.02). A greater percentage of subjects also reported satisfaction with the experimental treatment (55% vs 33%, P < 0.02), and these subjects were less likely to require upward dose titration at the final follow-up visit (53% vs 72%, P < 0.03). Consideration of Testim 1% gel in patients who have an inadequate response to prior T therapy is encouraged, although it is difficult to estimate the contribution of nonspecific study effects (eg, placebo) in this trial. [Copyright &y& Elsevier]

Introduction and Objective: The severity of lower urinary tract symptoms (LUTS) is associated with the severity of erectile dysfunction (ED; Rosen et al Eur Urol 2003; 44: 637-649). This raises the question: Does LUTS severity impact ED treatment response? Methods: We addressed this question using data from a randomized, double-blind, placebo-controlled study of the efficacy and safety of tadalafil dosed once a day in men with moderate to severe LUTS/BPH (International Prostate Symptom Score (IPSS) ≥ 3). Of 281 men enrolled, 81% (228) were sexually active and 68% (156/228) of those had a medical history of ED; these 156 patients were included in this post hoe analysis. Following a 4-week, single-blind, placebo run-in; patients were randomized to tadalafil (5mg, 6 weeks followed by dose escalation to 20mg, 6 weeks) or placebo (12 weeks). Change from baseline International Index of Erectile Function (IIEF) Erectile Function (EF) Domain scores are presented by baseline LUTS severity. Results: Tadalafil 5mg (6 weeks) and 5/20mg (12 weeks) significantly improved IIEF EF Domain scores vs placebo, IIEF EF Domain scores for patients with moderate LUTS did not differ significantly from scores for patients with severe LUTS. Improvements in IIEF EF Domain scores at 12 weeks were comparable to previous- ly reported scores in general ED populations. Conclusions: Tadalafil dosed once a day significantly improved erectile function compared with placebo in sexually active men with ED and moderate to severe LUTS secondary to BPH. In this study population, improvements in erectile function for patients with moderate or severe LLC LUTS were similar. IIEF EF Domain scores at 12 weeks for patients with either moderate or severe LUTS were comparable to IIEF EF Domain scores previously reported in the general ED population with on-demand tadalafil treatment. [ABSTRACT FROM AUTHOR]

The signs and symptoms of low testosterone in the aging male include erectile dysfunction, decreased libido, mood disturbances such as depression, loss of muscle mass, osteoporosis, and increase in body fat. Many of these signs and symptoms were previously believed to be part of the normal aging process, and only recently has treatment of low testosterone in the aging male been shown to provide long-term physical and mental improvement. In the past, oral and injectable testosterone delivery methods had disadvantages that limited their use, but the introduction of transdermal testosterone patches has allowed testosterone to be delivered into the circulation in a consistent fashion. Long-term use of these patches over the last 3 to 10 years has been effective in maintaining sexual function and bone and muscle mass, and from short-term studies it does not appear that testosterone treatment puts men at risk for the development of prostate cancer. A new topical gel formation (Testim) has been designed to provide consistent transdermal absorption of testosterone over 24 hours after a single dose.

In March 1998, a new sexual revolution began. It was at that time that Viagra, a pill for the treatment of male erectile dysfunction, was introduced. Release of this medication not only allowed scientists to identify the basic physiology of erectile functioning but also for the first time allowed men to reverse the natural aging process of loss of an erection. This, unfortunately, failed to address the other most important part of sexual relations: the female partner. It is not until recently that we have begun to recognize the vast importance of the couple's relationship. This paper reviews the pathophysiology of both male and female sexual dysfunctions and their relationships. It describes the testing process that is involved in the ideology and management of sexual dysfunction. The treatment options reviewed include the use of the older methods for male sexual dysfunction, as well as the new pharmacologic treatments and their potential. The treatment of female sexual dysfunction is also addressed.