197 A DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-WAY CROSSOVER STUDY USING THERMOGRAPHY TO ASSESS THE PHARMACODYNAMICS OF SILDENAFIL CREAM, 3.6% IN HEALTHY WOMEN Goldstein, S. 1 ; Kukkonen, T. 2 ; Monsef, A. 3 ; Goldstein, I. 4 1 San Diego Sexual Medicine; 2 University of Guelph; 3 Strategic Science & Technologies, LLC; 4 San Diego Sexual Medicine Introduction: Sildenafil Cream, 3.6% is a novel topical formulation in Phase 2 clinical development for the treatment of Female Sexual Arousal Disorder (FSAD), a sexual dysfunction characterized by diminished vaginal lubrication, decreased clitoral and labial sensation and reduced genital engorgement. Research to date supports the role of the NO-cGMP smooth muscle-mediated vasodilatory pathway in the female genital arousal response, advocating for the investigation of Sildenafil Cream, 3.6% as a first-in-class therapy for FSAD. Objectives: To evaluate the feasibility of thermography to assess the phar- macodynamics of Sildenafil Cream, 3.6% and to evaluate the preliminary efficacy of Sildenafil Cream, 3.6% compared to placebo cream, using ther- mography to assess genital blood flow and the Sexual Arousal Questionnaire to assess self-reported cognitive arousal and perception of genital arousal, in healthy women. Methods: Women aged 25 to 55 without sexual dysfunction were recruited to participate in this double-blind, placebo-controlled, 2-way crossover study (M age ¼ 36.3). A total of six women completed the three clinic visits for the study. At each visit, subjects viewed a neutral baseline film followed by a sexually explicit film while genital tempera- ture, a surrogate for blood flow, and thigh temperature (non-genital control) were continuously recorded using thermography. The Sexual Arousal Questionnaire was completed after each film. The first visit consisted of a medical screening and recording of sexual response with no cream intervention. Eligible subjects then completed two double-blind dosing visits, separated by a washout period, where subjects were ran- domized to receive Sildenafil Cream, 3.6% and placebo cream immedi- ately prior to viewing the sexually explicit film. Results: Repeated Measures ANOVAs examining both vestibular and clitoral temperature over the 30-minute sexually explicit film demonstrated significant differences in the clitoris between the Sildenafil Cream, 3.6% as compared to the no cream (p ¼.000, h p 2 ¼.32) and placebo cream (p ¼.05, h p 2 ¼.13) conditions. This significant difference was also present in the vestibule (no cream p ¼ .02, h p 2 ¼.16; placebo cream p ¼ .03, h p 2 ¼.14). There were no significant differences in genital temperature between the cream conditions during the neutral baseline film (p >.10) or in any of the thigh temperature measures (p >.10). Furthermore, in an analysis to investigate the onset of action of Sildenafil Cream, 3.6%, a significantly greater linear slope during minutes 11-15 of the sexually explicit film was demonstrated when compared to the placebo cream treatment group (p ¼ 0.02, h p 2 ¼.44). A MANOVA on self-reports of cognitive arousal and perception of genital arousal demonstrated significant differences with subjects reporting higher ratings of peak sexual arousal (p ¼ 0.03), moti- vation to have sex with partner (p ¼ 0.02), and vaginal lubrication/wetness (p ¼ 0.04) during Sildenafil Cream, 3.6% visits compared to placebo cream visits. Conclusions: Sildenafil Cream, 3.6% administered to healthy subjects without sexual dysfunction induced statistically and clinically significant increases in genital and self-reported measures of arousal compared to pla- cebo cream, exhibiting pharmacodynamic activity 11-15 minutes post-dose. These data support the potential for Sildenafil Cream, 3.6% to be a promising, on-demand treatment for FSAD patients. Disclosure: Work supported by industry: yes, by Strategic Science & Technologies, LLC. A consultant, employee (part time or full time) or shareholder is among the authors (Strategic Science & Technologies, LLC). 198 ASSOCIATIONS BETWEEN DOMAINS OF URINARY SYMPTOMS AND FEMALE SEXUAL DYSFUNCTION IN WOMEN WITH TYPE 1 DIABETES Gibbons, C. 1 ; Holt, S. 2 ; Braffett, B. 3 ; Agochukwu, N. 4 ; Sarma, A. 4 ; Wessells, H. 2 1 University of Washington School of Medicine; 2 University of Washington, Department of Urology and Diabetes Research Center; 3 George Washington University, Biostatistics Center; 4 University of Michigan Departments of Urology and Epidemiology Introduction: The prevalence of female sexual dysfunction (FSD) in women with type 1 diabetes mellitus (T1DM) is significant, but the etiology remains poorly understood. Objective: Our objective was to determine the influence of urinary symp- toms on FSD in women with T1DM. Methods: Sexually active women with T1DM participating in the urological ancillary study of the Epidemiology of Diabetes Interventions and Com- plications Study (UroEDIC) completed an abbreviated version of the Female Sexual Function Index measuring FSD, the American Urological Association Symptom Index measuring lower urinary tract symptoms (LUTS), the Sandvik Severity Index and other validated questionnaires measuring urinary incontinence (UI). Women were deemed to be symptomatic or non- symptomatic in each condition overall and in domains within each condition using standard cutpoints. Associations between symptoms of UI and LUTS and FSD were examined using logistic regression models adjusting for he- moglobin A1c, body mass index, age, and marital status. Results: Among sexually active women (N¼499) in the study the prevalence of FSD was 46.5% (N¼232), of UI was 25.1% (N¼125), and of LUTS was 19.2% (N¼96). UI was not associated with FSD, whereas LUTS were significantly associated with FSD overall (OR¼1.74, 95% CI 1.09, 2.77) and lower scores within the orgasm (OR¼1.88, 95% CI 1.15, 3.07) and satisfaction domains (OR¼2.09, 95% CI 1.13, 3.87). Incomplete emptying was the urinary symptom most strongly associated with FSD (OR¼2.69, 95% CI 1.36, 5.30), primarily via the satisfaction (OR¼2.74, 95% CI 1.25, 6.01) and pain (OR¼4.81, 95% CI 2.14, 10.81) domains. Of the women with FSD, 75% were symp- tomatic in the interest domain, 57% in the orgasm domain, 45% in the lubrication domain, 34% in the arousal domain, 25% in the satisfaction domain and 23% in the pain domain. Figure 1. Clitoral temperature change during the sexually explicit film. 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