Diane Lewis-D'Agostino's research while affiliated with Boehringer Ingelheim and other places

The Decreased Sexual Desire Screener is a brief diagnostic instrument for generalized acquired Hypoactive Sexual Desire Disorder in women. During the screening visit of 2 clinical trials, the authors assessed sensitivity of the Decreased Sexual Desire Screener in premenopausal women presenting with decreased sexual desire. The authors compared diagnoses of generalized acquired Hypoactive Sexual Desire Disorder made by clinicians who were not trained or specialized in the diagnosis of female sexual dysfunction using the Decreased Sexual Desire Screener with diagnoses made by expert clinicians after an extensive diagnostic interview. The sensitivity of the Decreased Sexual Desire Screener was 0.946 in a North American trial and 0.960 in a European trial.

To determine the most appropriate cutoff value for the Sexual Interest and Desire Inventory-Female (SIDI-F) score to discriminate between women with hypoactive sexual desire disorder (HSDD) and those with no female sexual dysfunction (FSD). The SIDI-F is a clinician-rated instrument consisting of 13 items designed to assess HSDD severity in women. The total score ranges from 0 to 51, with higher scores indicating better sexual function. Data from patients enrolled in a North American nontreatment study and a European nontreatment study were analyzed. Both studies were 4-week, prospective, multicenter trials designed to assess the reliability and validity of the SIDI-F. Only patients with HSDD or no FSD were included in this analysis. Receiver operating characteristics (ROC) analysis was used to determine the ability of the SIDI-F to differentiate between patients with HSDD and those with no FSD at baseline. A total of 428 women were included in this analysis: 174 from North America (HSDD 113, no FSD 61) and 254 from Europe (HSDD 130, no FSD 124). In the North American study, a SIDI-F cutoff score of 33 minimized the difference between sensitivity (94.7%) and specificity (93.4%). In the European study, SIDI-F cutoff scores of both 33 and 34 minimized the difference between sensitivity (95.2%) and specificity (94.4%). In appropriately screened women, a SIDI-F score of ≤33 indicates the presence of HSDD.

The Sexual Interest and Desire Inventory-Female (SIDI-F) is a 13-item scale developed as a clinician-administered assessment tool to measure hypoactive sexual desire disorder (HSDD) severity in women. To estimate the reliability and validity of the SIDI-F as a measure of HSDD severity. Women, aged 18-65 years, with primary HSDD, Female Sexual Arousal Disorder (FSAD), or no Female Sexual Dysfunction (no FSD) participated in two nontreatment studies (in North America and Europe). On days 0 and 28, subjects were assessed using the SIDI-F, Female Sexual Function Index (FSFI), Changes in Sexual Functioning Questionnaire-Female (CSFQ-F), Locke-Wallace Marital Adjustment Test (MAT) and the Female Sexual Distress Scale (FSDS). Discriminant validity, convergent validity, divergent validity, test-retest validity, and internal consistency of the SIDI-F. The North American study enrolled women with HSDD (N = 113), FSAD (N = 49) and no FSD (N = 61); the European study enrolled women with HSDD (N = 130) and no FSD (N = 124). In both studies, mean SIDI-F total score for women with HSDD was lower than for those with no FSD (P < 0.001, for all) demonstrating discriminant validity. Further, mean SIDI-F total score for women with HSDD was lower than for those with FSAD in the North American study (P < 0.001). Convergent validity with the FSFI and CSFQ-F and divergent validity with MAT were demonstrated. Test-retest reliability and internal consistency were high. The SIDI-F is a valid and reliable measure of HSDD severity in women.

Sex-related distress is integral to the diagnosis of hypoactive sexual desire disorder (HSDD). This article describes the results of three prospective, non-treatment validation studies (two North American and one European), each testing over 200 participants with HSDD, other types of female sexual dysfunction (FSD), or no FSD in which the 12-item Female Sexual Distress Scale(©) (FSDS(©)), the 13-item FSDS-Revised(©)(FSDS-R(©)), and a single question asked using a daily electronic diary (the eDiary For HSDD Trials(©); eDiary) were used to measure sex-related distress. FSDS results with 30- and seven-day recall were equivalent. The results observed with FSDS-R Item 13 (a single question assessing concern due to low sexual desire) were comparable to the FSDS. Mean eDiary monthly distress scores were closer to the minimum possible score (equivalent to "a little bit" of distress) and were about twice as variable as FSDS or FSDS-R Item 13 scores in participants with HSDD. All three measures confirmed that there is more distress in women with HSDD compared to women with no sexual dysfunction at all time points, demonstrating discriminant validity.

An accurate diagnosis of Hypoactive Sexual Desire Disorder (HSDD) currently relies on a time-consuming interview with an expert clinician. Limited access to such expertise means that many women with HSDD remain undiagnosed. The Decreased Sexual Desire Screener (DSDS) was developed to provide clinicians who are neither trained nor specialized in Female Sexual Dysfunction (FSD) with a brief diagnostic procedure for the diagnosis of generalized acquired HSDD in women. A prospective non-treatment multicenter study enrolled 263 women at 27 centers in North America in order to test the validity of the DSDS for diagnosing generalized acquired HSDD in women. Subjects completed the DSDS at the screening visit and their answers were reviewed with a clinician who was not an expert in FSD ("non-expert clinician"). Separately and while being unaware of the non-expert clinician's diagnosis, an expert clinician conducted a standard diagnostic interview. Diagnostic outcomes (generalized acquired HSDD or not) were compared. Primary endpoints included the sensitivity and specificity of the DSDS relative to the standard diagnostic interview. Subject and non-expert clinician debriefing were obtained via a written, structured interview. This ensured that a large sample could be tested under uniform conditions across multiple sites. Diagnostic assessment by DSDS and standard diagnostic interview were in agreement in 85.2% (224/263) of cases, with the sensitivity and specificity of the DSDS 83.6% and 87.8%, respectively. Debriefing showed that the five DSDS questions were well understood by 85.4% (76/89) of subjects included in the debriefing exercise, while non-expert clinicians considered the DSDS questions adequate to diagnose HSDD in 92.9% (235/253) of cases. The DSDS is a sensitive and specific brief diagnostic instrument for generalized acquired HSDD in women that is quick and easy to use.

Objective To present the design of three Phase III North American trials, which will assess the efficacy and safety profile of flibanserin, a novel centrally acting agent, in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD). Methods The Dahlia (511.70), Violet (511.71), and Daisy (511.75) studies are prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trials, designed to assess the effects of flibanserin in premenopausal women with a primary diagnosis of generalized, acquired HSDD. Every study consists of a 4-week baseline period (no medication), 24-week double-blind treatment period, and 4-week follow-up period after discontinuation of study medication. Designs are identical except for the flibanserin doses tested: 25 mg bid/50 mg bid/50 mg qhs/placebo in Dahlia; 50 mg qhs/100 mg qhs/placebo in Violet; 25 mg bid/50 mg qhs uptitrated to 50 mg bid/50 mg qhs uptitrated to 100 mg qhs/placebo in Daisy. Co-primary endpoints are monthly sum of responses to a daily question on sexual desire measured by an electronic diary (e-Diary For HSDD Trials©; e-Diary), comparing 4-week baseline with weeks 21-24, and change in frequency of satisfying sexual events, measured by the e-Diary. Secondary endpoints include change in distress related to sexual desire. Prospective safety assessments include evaluation of menses and sex hormones adverse events. Results These trials are ongoing. Results will be presented in 2009. Conclusions These North American Phase III trials will determine the efficacy and safety of 24 weeks’flibanserin treatment in premenopausal women with HSDD, and determine minimal effective and most tolerable dosages for this indication. Source of Support Funding was provided by Boehringer Ingelheim.

Introduction: The concept of sexually related personal distress is currently central to the diagnosis of all female sexual dysfunctions (FSD). In the current study, we have focused on validating a slightly revised version of the Female Sexual Distress Scale (FSDS), the FSDS-Revised (FSDS-R), to enhance the sensitivity of the instrument with patients suffering from hypoactive sexual desire disorder (HSDD). In addition, we have attempted to extend the validation generalizability of the scale by demonstrating that both instruments possess reliability and discriminative validity in premenopausal women with HSDD. Aim: To assess the validity of the revised version of the FSDS, the FSDS-R, for measuring sexual distress in women with HSDD. Methods: A prospective methodological study carried out at 27 centers in North America enrolled 296 women aged 18-50 years with HSDD, another female sexual dysfunction (FSD), or no FSD. The subjects completed the FSDS-R at baseline, day 7, and day 28, with a 30-day recall at baseline and with a 7-day recall on days 7 and 28. Main outcome measures: Receiver operating characteristic (ROC) analyses of FSDS, FSDS-R, and FSDS-R item 13 were used for the differentiation of HSDD from no FSD, while intraclass correlation coefficient (ICC) was used to estimate test-retest reliability. Cronbach's coefficient alpha was used to measure the internal consistency of the FSDS-R and Pearson's correlation coefficient to assess FSDS, FSDS-R, and FSDS-R item 13 with different recall periods (7 and 30 days). Results: Mean total FSDS, FSDS-R, and FSDS-R item 13 scores with either recall period were significantly higher (P < 0.0001) in women with FSD or HSDD than in women with no FSD, showing both tests had discriminant validity. ROC analysis confirmed these findings, while an ICC of >0.74 showed the test-retest reliability of both scales, including FSDS-R item 13 alone, and Cronbach's coefficient alpha of >0.86 confirmed the internal consistency of both tests. Conclusions: Consistent with the FSDS, the FSDS-R demonstrated good discriminant validity, high test-retest reliability, and a high degree of internal consistency in measuring sexually related personal distress in women with HSDD. FSDS-R item 13 alone also demonstrated good discriminant validity and test-retest reliability.