Sheryl A. Kingsberg

Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial.

OBJECTIVE: To assess the efficacy and safety of a 300 μg/d testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women on concomitant estrogen therapy. METHODS: Five hundred thirty-three women with hypoactive sexual desire disorder who had undergone previous hysterectomy and bilateral oophorectomy were enrolled in a 24-week, multicenter, double-blind, placebo-controlled trial. Patients were randomly assigned to receive placebo or the testosterone patch twice weekly. The primary efficacy endpoint was change from baseline at week 24 in the frequency of total satisfying sexual activity, measured by the Sexual Activity Log. Secondary measures included sexual desire using the Profile of Female Sexual Function and personal distress as measured by the Personal Distress Scale. Hormone levels, adverse events, and clinical laboratory measures were reviewed. RESULTS: Total satisfying sexual activity significantly improved in the testosterone patch group compared with placebo after 24 weeks (mean change from baseline, 1.56 compared with 0.73 episodes per 4 weeks, P = .001). Treatment with the testosterone patch also significantly improved sexual desire (mean change, 10.57 compared with 4.29, P < .001) and decreased personal distress (P = .009). Serum free, total, and bioavailable testosterone concentrations increased from baseline. Overall, adverse events were similar in both groups (P > .05). The incidence of androgenic adverse events was higher in the testosterone group; most androgenic adverse events were mild. CONCLUSION: In surgically menopausal women with hypoactive sexual desire disorder, a 300 μg/d testosterone patch significantly increased satisfying sexual activity and sexual desire, while decreasing personal distress, and was well tolerated through up to 24 weeks of use. LEVEL OF EVIDENCE: I

Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) Survey

INTRODUCTION Vulvar and vaginal atrophy (VVA) is a chronic medical condition experienced by many postmenopausal women. Symptoms include dyspareunia (pain with intercourse), vaginal dryness, and irritation and may affect sexual activities, relationships, and activities of daily life. AIM The aim of this study is to characterize postmenopausal womens experience with and perception of VVA symptoms, interactions with healthcare professionals (HCPs), and available treatment options. METHODS An online survey was conducted in the United States in women from KnowledgePanel(®) , a 56,000-member probability-selected Internet panel projectable to the overall US population. Altogether, 3,046 postmenopausal women with VVA symptoms (the largest US cohort of recent surveys) responded to questions about their knowledge of VVA, impact of symptoms on their activities, communication with HCPs, and use of available treatments. MAIN OUTCOME MEASURES Percent is calculated as the ratio of response over total responding for each question for all and stratified participants. RESULTS The most common VVA symptoms were dryness (55% of participants), dyspareunia (44%), and irritation (37%). VVA symptoms affected enjoyment of sex in 59% of participants. Additionally, interference with sleep, general enjoyment of life, and temperament were reported by 24%, 23%, and 23% of participants, respectively. Few women attributed symptoms to menopause (24%) or hormonal changes (12%). Of all participants, 56% had ever discussed VVA symptoms with an HCP and 40% currently used VVA-specific topical treatments (vaginal over-the-counter [OTC] products [29%] and vaginal prescription therapies [11%]). Of those who had discussed symptoms with an HCP, 62% used OTC products. Insufficient symptom relief and inconvenience were cited as major limitations of OTC products and concerns about side effects and cancer risk limited use of topical vaginal prescription therapies. CONCLUSIONS VVA symptoms are common in postmenopausal women. Significant barriers to treatment include lack of knowledge about VVA, reluctance to discuss symptoms with HCPs, safety concerns, inconvenience, and inadequate symptom relief from available treatments.

The Utian Quality of Life (UQOL) Scale: Development and validation of an instrument to quantify quality of life through and beyond menopause

ObjectiveQuality of life (QOL) is an outcome variable requiring measurement in clinical care or pivotal regulatory trial research. Current menopause QOL measures are mostly life phase or disease symptom inventories or scores. Believing that QOL should refer more to “sense of well-being,” we have developed the Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. DesignA pool of items sampling various aspects of well-being was developed. Peri- and postmenopausal women (n = 327) responded to the items, and their responses were subjected to a factor analysis. Four factors emerged, each representing a QOL domain. The resulting 23-item instrument was validated in a geographically and socioeconomically diverse sample of peri- and postmenopausal women using the Short Form-36, an established, frequently used QOL inventory. QOL domains were subjected to confirmatory factor analyses, formal item analysis was completed, and the measure was assessed for reliability and validity, including a second sample of women (n = 270). ResultsWomen (n = 597; mean age, 52.9 years) from 12 communities across the United States completed the measure. The UQOL seems to reflect four components of QOL: occupational QOL, health QOL, emotional QOL, and sexual QOL. The questionnaire and scoring system are presented. ConclusionWe are reporting on the process of validating an instrument for quantifying sense of well-being in a perimenopausal population. Substantial reliability and validity estimates for the scale and its subscales support the UQOL as a valuable new tool for use in clinical research and practice.

The Impact of Aging on Sexual Function in Women and Their Partners

Aging has a powerful impact on the quality of relationship and sexual functioning. The psychological impact of aging after midlife is a particularly timely topic, given improved medical and psychological understanding of sexuality in both women and men as well as significant improvement in the conceptualization of female sexuality and evolving treatment advances for female sexual dysfunctions. It is time to dispel the stereotype of the midlife woman in order to more effectively address emotional and sexual issues arising in her relationships. Regardless of the length or nature of the relationship, its quality is enhanced by emotional intimacy, autonomy without too much distance, an ability to manage stress, and to maintain a positive perception of self and the relationship. To understand and treat effects of aging on sexuality, it is important to address the three components of sexual desire: drive, beliefs/values, and motivation, as well as the social context of a womans life. It is also essential to understand how the physiological changes in female as well as male sexual functioning impact desire. Further, other health-related changes that occur with aging must be recognized and addressed.

Impact of vulvovaginal health on postmenopausal women: A review of surveys on symptoms of vulvovaginal atrophy

Several recent, large-scale studies have provided valuable insights into patient perspectives on postmenopausal vulvovaginal health. Symptoms of vulvovaginal atrophy, which include dryness, irritation, itching, dysuria, and dyspareunia, can adversely affect interpersonal relationships, quality of life, and sexual function. While approximately half of postmenopausal women report these symptoms, far fewer seek treatment, often because they are uninformed about hypoestrogenic postmenopausal vulvovaginal changes and the availability of safe, effective, and well-tolerated treatments, particularly local vaginal estrogen therapy. Because women hesitate to seek help for symptoms, a proactive approach to conversations about vulvovaginal discomfort would improve diagnosis and treatment.

The North American Menopause Society recommendations for clinical care of midlife women

In celebration of the 25th anniversary of The North American Menopause Society (NAMS), the Society has compiled a set of key points and clinical recommendations for the care of midlife women. NAMS has always been a premier source of information about menopause for both healthcare providers and midli

Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial

ObjectiveThis study aimed to assess the efficacy and safety of flibanserin, a serotonin receptor 1A agonist/serotonin receptor 2A antagonist, in postmenopausal women with hypoactive sexual desire disorder (HSDD). MethodsNaturally postmenopausal women with HSDD received flibanserin 100 mg once daily at bedtime (n = 468) or placebo (n = 481) for 24 weeks. Co–primary endpoints were changes from baseline to week 24 in the number of satisfying sexual events (SSEs) across 28 days and in the Female Sexual Function Index (FSFI) desire domain score. Secondary endpoints included change from baseline in Female Sexual Distress Scale—Revised (FSDS-R) Item 13 score (which assesses distress due to low sexual desire), FSDS-R total score, and FSFI total score. The Patient Benefit Evaluation was asked on treatment discontinuation. ResultsThere were significant improvements with flibanserin versus placebo in the mean (SE) changes in the number of SSEs (1.0 [0.1] vs 0.6 [0.1]), FSFI desire domain score (0.7 [0.1] vs 0.4 [0.1]), FSDS-R Item 13 score (−0.8 [0.1] vs −0.6 [0.1]), FSDS-R total score (−8.3 [0.6] vs −6.3 [0.6]), and FSFI total score (4.2 [0.4] vs 2.7 [0.4]; all P < 0.01). More women on flibanserin (37.6%) than women on placebo (28.0%) reported experiencing meaningful benefits from the study medication on treatment discontinuation. The most frequent adverse events associated with flibanserin were dizziness, somnolence, nausea, and headache. ConclusionsIn naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire, improvement in the number of SSEs, and reduced distress associated with low sexual desire, and is well tolerated.

The current outlook for testosterone in the management of hypoactive sexual desire disorder in postmenopausal women.

INTRODUCTION Hypoactive sexual desire disorder (HSDD) is a common clinical problem in women, especially those who have experienced surgical menopause. Because androgen levels decline with age and drop dramatically following bilateral oophorectomy, it has been hypothesized that reduced levels of testosterone are related to diminished desire. AIM As presented at a continuing medical education satellite symposium during the 2008 annual meeting of the International Society for the Study of Womens Sexual Health, to review the current state of knowledge about the physiologic effects of testosterone in postmenopausal women, the effects of transdermal testosterone delivery in surgically menopausal women with HSDD, and ongoing studies of a transdermal testosterone gel. METHODS A review of the pertinent literature, including recent presentations. MAIN OUTCOME MEASURES Results from the Womens International Study of Health and Sexuality; and studies utilizing the Brief Index of Sexual Functioning for Women, the Psychological General Well-Being Index, and validated instruments that assess female sexual function: the Sexual Activity Log, the Profile of Female Sexual Function, and the Personal Distress Scale. RESULTS Surgically menopausal women receiving testosterone experience significant increases in total satisfying sexual activity vs. women receiving placebo, significant improvement in all domains of sexual function, and decreases in personal distress, with a favorable safety profile. CONCLUSIONS Testosterone deficiency may be considered among the underlying causes of HSDD. Currently, testosterone is available to women in the United States only via off-label prescribing or by unregulated compounding of testosterone preparations. New safety trials will examine the long-term safety of testosterone gel in surgically menopausal women with HSDD who are at high risk of cardiovascular disease or breast cancer.

Clarifying Vaginal Atrophy's Impact on Sex and Relationships (CLOSER) survey: Emotional and physical impact of vaginal discomfort on North American postmenopausal women and their partners

ObjectiveThis study aims to determine the emotional and physical impact of vaginal atrophy on North American postmenopausal women and their male partners. MethodsA weighted sample of 1,000 married or cohabiting North American postmenopausal women aged 55 to 65 years with vaginal discomfort and 1,000 male partners of postmenopausal women aged 55 to 65 years who experienced vaginal discomfort participated in the Clarifying Vaginal Atrophy’s Impact on Sex and Relationships (CLOSER) online survey to determine the impact of vaginal discomfort and local estrogen therapy on intimacy, relationships, and women’s self-esteem. ResultsVaginal discomfort caused most surveyed North American women to avoid intimacy (58%), experience loss of libido (64%), and experience pain associated with sex (64%). Most surveyed North American men also believed that vaginal discomfort caused their partners to avoid intimacy (78%), experience loss of libido (52%), and find sex painful (59%). Approximately 30% of North American women and men cited vaginal discomfort as the reason they ceased having sex altogether. North American women who used local estrogen therapy to treat their vaginal discomfort reported less painful sex (56%), more satisfying sex (41%), and improved sex life (29%). Most men reported looking forward to having sex (57%) because of their partner’s use of local estrogen therapy. ConclusionsLocal estrogen therapy ameliorates the negative impact of vaginal atrophy on the intimate relationships of North American postmenopausal women and their male partners. Additional education and awareness efforts about the symptoms of and available treatments for vaginal atrophy may be of further benefit to North American partners.

Who's Afraid of the G‐spot?

INTRODUCTION No controversy can be more controversial than that regarding the existence of the G-spot, an anatomical and physiological entity for women and many scientists, yet a gynecological UFO for others. METHODS The pros and cons data have been carefully reviewed by six scientists with different opinions on the G-spot. This controversy roughly follows the Journal of Sexual Medicine Debate held during the International Society for the Study of Womens Sexual Health Congress in Florence in the February of 2009. MAIN OUTCOME MEASURE To give to The Journal of Sexual Medicines reader enough data to form her/his own opinion on an important topic of female sexuality. RESULTS Expert #1, who is JSMs Controversy section editor, reviewed histological data from the literature demonstrating the existence of discrete anatomical structures within the vaginal wall composing the G-spot. He also found that this region is not a constant, but can be highly variable from woman to woman. These data are supported by the findings discussed by Expert #2, dealing with the history of the G-spot and by the fascinating experimental evidences presented by Experts #4 and #5, showing the dynamic changes in the G-spot during digital and penile stimulation. Experts #3 and #6 argue critically against the G-spot discussing the contrasting findings so far produced on the topic. CONCLUSION Although a huge amount of data (not always of good quality) have been accumulated in the last 60 years, we still need more research on one of the most challenging aspects of female sexuality.