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Biomedical subjects

Candace Brown

Publications and source records attributed to Candace Brown.

8 recordsLinked to original sources

Vulvodynia: a state-of-the-art consensus on definitions, diagnosis and management.

Vulvodynia is a chronic pain syndrome affecting up to 18% of the female population. Despite its high prevalence and associated distress, the etiology, diagnosis and clinical management of the disorder have not been clearly delineated. This "white paper" describes the findings and recommendations of a consensus conference panel based on a comprehensive review of the published literature on vulvodynia in addition to expert presentations on research findings and clinical management approaches. The consensus panel also identified key topics and issues forfurther research, including the role of inflammatory mechanisms and genetic factors and psychosexual contributors.

Biomedical Research↗

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

OBJECTIVE: To assess the efficacy and safety of a 300 mug/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 mug/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.

Administration, Cutaneous↗

Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder.

OBJECTIVE: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. METHODS: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 microg. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4). RESULTS: Scores on the total Daily Record of Severity of Problems decreased by -37.49 in the drospirenone/ethinyl estradiol group and by -29.99 in the placebo group (adjusted mean difference -7.5, 95% confidence interval [CI] -11.2 to -3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by -19.2 and -15.3 in active-treatment and placebo groups, respectively (adjusted mean difference -3.9, 95% CI -5.84 to -2.01; P = .003); physical symptom scores were reduced by -10.7 and -8.6 in active-treatment and placebo groups, respectively (adjusted mean difference -2.1, 95% CI -3.3 to -0.95; P < .001); and behavioral symptom scores were reduced by -7.7 and -6.2 in active-treatment and placebo groups, respectively (adjusted mean difference -1.5, 95% CI -2.251 to -0.727; P < .001). Response, defined as a 50% decrease in daily symptom scores, occurred in 48% of the active-treatment group and 36% of the placebo group (relative risk 1.7, 95% CI 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients. CONCLUSION: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 mug improves symptoms associated with premenstrual dysphoric disorder. LEVEL OF EVIDENCE: I.

Adult↗

Persistent sexual arousal syndrome: a descriptive study.

INTRODUCTION: Persistent sexual arousal disorder (PSAS) is a poorly documented condition characterized by persistent genital arousal in the absence of conscious feelings of sexual desire. AIM: To determine whether there are replicable features associated with PSAS, to describe salient characteristics of women reporting this condition, and to determine predictors of distress. METHODS: A 46-item Internet survey containing demographic information, symptom description, triggers, exacerbation and relief measures, distress ratings, and life and sexual satisfaction was placed on a secure server. MAIN OUTCOME MEASURES: Frequency analyses of descriptive data, and stepwise multiple regression analysis to identify independent predictors of level of distress. RESULTS: Of the 103 respondents, most were in good health, well educated, and in long-term relationships. Ninety-eight percent of respondents met at least one criterion for PSAS and 53% met all five criteria. Involuntary genital and clitoral arousal persisting for extended time periods, genital arousal unrelated to subjective feelings of sexual desire, and genital arousal not relieved with orgasms were the most frequently endorsed features associated with this syndrome. Symptom triggers included sexual stimulation, masturbation, stress, and anxiety. Distress about the condition was low in 25%, moderate in 35%, and high in 40% of respondents. The strongest predictors of distress were intrusive and unwanted feelings of genital arousal (P < 0.0001), continuous symptoms (P < 0. 001), feelings of unhappiness (P < 0.03), shame (P = 0.0001) and worry (P = 0.01), reduced sexual satisfaction (P < 0.004), enjoyment of symptoms some of the time (P = 0.01), and relationship status (P < 0.004). CONCLUSIONS: The results of this research support the description of a condition (persistent sexual arousal) involving involuntary genital and clitoral arousal unrelated to subjective feelings of sexual desire which persists despite one or more orgasms and which usually feels intrusive and unwanted. Varying levels of distress were identified with this condition as well as a variety of primarily negative emotional reactions.

Adolescent↗

Health and economic impact of the premenstrual syndrome.

OBJECTIVE: To explore the effect of the premenstrual syndrome (PMS) on health-related quality of life, health care utilization and occupational functioning. STUDY DESIGN: A cross-sectional cohort study of women prospectively diagnosed with PMS. RESULTS: Among women completing the survey, 28.7% were diagnosed with PMS. Women with PMS had significantly lower scores on the Mental Component Summary (MCS) and Physical Component Summary (PCS) scale scores of the Medical Outcomes Study Short Form-36 as compared to women without PMS (MCS = 42.8 vs. 49.5, P < .001, and PCS = 51.1 vs. 53.0, P = .04). Women with PMS reported reduced work productivity, interference with hobbies and greater number of work days missed for health reasons (P < .001). In addition, women with PMS experienced an increased frequency of ambulatory health care provider visits (P = .04) and were more likely to accrue > $500 in visit costs over 2 years (P < .006). CONCLUSION: Findings from this study suggest that premenstrual symptoms significantly affect health-related quality of life and may result in increased health care utilization and decreased occupational productivity.

Absenteeism↗

A new monophasic oral contraceptive containing drospirenone. Effect on premenstrual symptoms.

OBJECTIVE: To determine whether a new monophasic oral contraceptive containing drospirenone/ethinyl estradiol reduces premenstrual symptoms. STUDY DESIGN: In an open-label study measuring intrasubject changes in premenstrual symptoms and comparing effects between women who were new users of oral contraceptives and those who switched from previous contraceptives, ethinyl estradiol (30 micrograms) and drospirenone (3 mg) were administered for 13 menstrual cycles to 326 healthy women aged 18-35 years. Subjects completed the 23-item Women's Health Assessment Questionnaire at baseline and at the end of the sixth cycle. RESULTS: At the end of cycle 6, premenstrual and menstrual symptom scores on the negative affect and water retention scales were reduced significantly relative to baseline, as was increased appetite during the premenstrual and menstrual phases. Similar improvements were seen among new users of hormonal contraceptives and those who switched from previous contraceptives. Impaired concentration scale scores were not significantly reduced from baseline, and assessments of undesired hair changes and feelings of well-being did not change appreciably. CONCLUSION: An oral contraceptive containing drospirenone/ethinyl estradiol may reduce the premenstrual symptoms of negative affect, water retention and increased appetite.

Adolescent↗

Efficacy and safety of topical alprostadil cream for the treatment of female sexual arousal disorder (FSAD): a double-blind, multicenter, randomized, and placebo-controlled clinical trial.

We evaluated the efficacy and safety of three doses of a novel alprostadil cream in a randomized, double-blind, placebo-controlled study in 94 women presenting with female sexual arousal disorder of at least 6 month s duration. We sent the subjects home with 10 premeasured doses of 500 g, 1000 g, or 1500 g alprostadil or a placebo cream to be applied to the vulvar area prior to vaginal intercourse over a period of 6 weeks. The primary efficacy parameter, the arousal success rate (as measured by diary responses to the Female Sexual Encounter Profile [FSEP]), was highest in the alprostadil 1000 g group and lowest in the 500 g group, but the responses were not different from that of the placebo cream, at the p = 0.05 level, for any of the three alprostadil doses. However, the change from baseline for Item 6 of the Female Sexual Function Index (FSFI; Rosen et al., 2000; satisfaction with arousal during sexual activity) suggested an important dose-related trend (p = 0.173; 1500 g versus placebo). The mean percent responder rate (responder = > 50% arousal success rate with > 3 sexual attempts) suggested a dose-response effect (p = 0.157; 1500 g versus placebo). Adverse events were generally mild or moderate in intensity and mainly involved localized reactions in the genital area.

Administration, Cutaneous↗

Profile of Female Sexual Function: a patient-based, international, psychometric instrument for the assessment of hypoactive sexual desire in oophorectomized women.

OBJECTIVE: The purpose of this study was to develop a self-administered, patient-based questionnaire to assess loss of sexual desire and associated symptoms in postmenopausal women with hypoactive sexual desire disorder (HSDD) experiencing distress. DESIGN: Preliminary items and domains of sexual function were identified through individual and focus group interviews with postmenopausal women in the United States and Europe. A subset of items was selected for translation and further analysis. Cognitive interviews were conducted with women with HSDD and non-HSDD women in eight countries to ensure items would have the same meaning in seven languages. The resulting instrument was tested in 325 oophorectomized women with HSDD and 255 age-matched nonoophorectomized control women in the United States, Canada, Europe, and Australia. RESULTS: Psychometric item reduction analyses resulted in 37 items organized into seven domains characterizing female sexual function in postmenopausal women with HSDD. Excellent reliability and validity of the domains of the Profile of Female Sexual Function (PFSF) were observed in all geographic areas tested. Statistically significant differences between oophorectomized women with low libido and control women were found for all domains and all geographic areas. CONCLUSIONS: The PFSF is a new instrument specifically designed for measurement of sexual desire in oophorectomized women with low libido. Robust psychometric properties have been established in a large number of geographic regions and languages, making it useful for assessing therapeutic change in multinational clinical trials.

Adult↗