PD36-06 TWO-ARM, PROSPECTIVE, OPEN-LABEL, PILOT STUDY OF FLIBANSERIN VERSUS FLIBANSERIN AND SEX THERAPY IN WOMEN WITH HSDD

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Female (PD36)1 Apr 2020PD36-06 TWO-ARM, PROSPECTIVE, OPEN-LABEL, PILOT STUDY OF FLIBANSERIN VERSUS FLIBANSERIN AND SEX THERAPY IN WOMEN WITH HSDD Sue Goldstein*, Rose Hartzell-Cushanick, Caroline Cochran, Noel Kim, and Irwin Goldstein Sue Goldstein*Sue Goldstein* More articles by this author , Rose Hartzell-CushanickRose Hartzell-Cushanick More articles by this author , Caroline CochranCaroline Cochran More articles by this author , Noel KimNoel Kim More articles by this author , and Irwin GoldsteinIrwin Goldstein More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000907.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The most common sexual dysfunction in women is Hypoactive Sexual Desire Disorder (HSDD) with both biologic and psychologic components. Flibanserin was the first FDA-approved medication indicated for safe and effective treatment of HSDD in premenopausal women, but it has also been studied in postmenopausal women with results. Psychological and medical assessments are routinely performed in our sexual medicine practice. The aim of this pilot study was to compare the efficacy of flibanserin alone versus flibanserin with concomitant sex therapy in treating pre- and post-menopausal women with HSDD. METHODS: This open-label, prospective, 2-arm study was conducted at a single research center. Subjects (n = 17) with HSDD meeting inclusion and exclusion received flibanserin 100 mg qhs for 8-weeks. After this run-in period, flibanserin responders were randomized 1:1 to receive study medication alone (n = 5) versus study medication and nine sex therapy sessions (n = 4) over an additional 12 weeks. Responders were defined by a score of 1- 3 on the Patient Global Impression of Improvement (PGI-I). Validated outcome measures, including the Female Sexual Function Index (FSFI) and Female Sexual Distress Score (FSD-DAO) were completed at baseline, 8 weeks and end of study (12 weeks after randomization). Changes in FSFI from the flibanserin responder group at 8 weeks to the end of study (20 weeks) were compared with changes in the flibanserin responder and sex therapy group from the same time period. RESULTS: All subjects showed improvement of HSDD as only responders were randomized. Subjects receiving sex therapy had relationship issues that traditionally respond to sex therapy. FSFI total scores were significantly higher for patients who were in the combined flibanserin/sex therapy group compared to flibanserin alone (p = 0.03). FSFI domain scores in sexual desire, arousal, lubrication and orgasm were consistently higher in the combined group than flibanserin alone, although differences were not statistically significant. Distress, satisfaction and pain assessments were similar for both treatment groups. CONCLUSIONS: The addition of sex therapy to flibanserin treatment for HSDD in women who initially had some response to flibanserin significantly increased overall sexual function compared to flibanserin treatment alone. Although more research is needed, these pilot data suggest that use of a multidisciplinary treatment paradigm may result in better treatment outcomes in patients with HSDD. Source of Funding: Funded by an Investigator Initiated Research Grant from Valeant Pharmaceuticals. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e725-e725 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sue Goldstein* More articles by this author Rose Hartzell-Cushanick More articles by this author Caroline Cochran More articles by this author Noel Kim More articles by this author Irwin Goldstein More articles by this author Expand All Advertisement PDF downloadLoading ...