{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T04:57:02Z","timestamp":1787806622886,"version":"build-2784847793"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2018,3,1]],"date-time":"2018-03-01T00:00:00Z","timestamp":1519862400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"},{"start":{"date-parts":[[2018,3,1]],"date-time":"2018-03-01T00:00:00Z","timestamp":1519862400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011284","name":"Valeant Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011284","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jsm.jsexmed.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2018,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>To evaluate the safety of flibanserin in premenopausal and naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) in an open-label extension (OLE) study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Aim<\/jats:title>\n                  <jats:p>To examine the safety and tolerability of flibanserin 100 mg once daily at bedtime in the treatment of premenopausal and naturally postmenopausal women with HSDD in a multicenter 28-week OLE study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients entering this study received flibanserin or placebo in the double-blinded, placebo-controlled trials of premenopausal and postmenopausal women and in a pharmacokinetic study of postmenopausal women.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Outcomes<\/jats:title>\n                  <jats:p>The primary end point of this OLE study was the incidence of adverse events (AEs). Secondary exploratory efficacy measures included the Female Sexual Distress Scale\u2013Revised (FSDS-R) total score and FSDS-R item 13 (distress owing to low desire) score and the Female Sexual Function Index (FSFI) total score. Because the sponsor terminated the study early at discontinuation of the development of flibanserin, only descriptive statistics were calculated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of the 595 patients receiving study medication, 346 and 249 patients were premenopausal and postmenopausal, respectively. The mean number of days of exposure to flibanserin was 72.8 (SD\u00a0= 41.6). AEs were reported by 352 patients (59.2%), and most AEs (93.8%) were mild or moderate. The most common AEs (\u22655%) were dizziness (9.6%), somnolence (8.6%), insomnia (6.2%), and nausea (5.7%). There were no flibanserin-related serious AEs and no instances of suicidal ideation. The safety profile of flibanserin was similar for premenopausal and postmenopausal women. The FSDS-R total scores and FSDS-R item 13 scores were numerically lower at weeks 4, 12, and 20 than at baseline (decrease in distress owing to low desire) for premenopausal and postmenopausal women. Mean FSFI total scores were numerically higher at weeks 4, 12, and 20 than at baseline, irrespective of menopausal status of the patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Implications<\/jats:title>\n                  <jats:p>The results of this study support the safety and tolerability of flibanserin for the treatment of HSDD in premenopausal and naturally postmenopausal women.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Strengths and Limitations<\/jats:title>\n                  <jats:p>Although this open-label study was designed to be 28 weeks long, it was discontinued early by the sponsor, and patients\u2019 maximum duration of exposure to flibanserin was 23.9 weeks. The open-label design and lack of a placebo-controlled arm are other study limitations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In this open-label study, flibanserin 100 mg once daily at bedtime was generally safe and well tolerated by premenopausal and naturally postmenopausal women with HSDD.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1016\/j.jsxm.2017.12.016","type":"journal-article","created":{"date-parts":[[2018,3,5]],"date-time":"2018-03-05T12:14:46Z","timestamp":1520252086000},"page":"387-395","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":11,"title":["Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study"],"prefix":"10.1093","volume":"15","author":[{"given":"James A.","family":"Simon","sequence":"first","affiliation":[{"name":"George Washington University and Women\u2019s Health & Research Consultants , Washington, DC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard","family":"Derogatis","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine , Baltimore, MD , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Portman","sequence":"additional","affiliation":[{"name":"Columbus Center for Women\u2019s Health Research , Columbus, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Brown","sequence":"additional","affiliation":[{"name":"Valeant Pharmaceuticals North America , Bridgewater, NJ , USA"},{"name":"LLC , Bridgewater, NJ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Yuan","sequence":"additional","affiliation":[{"name":"Valeant Pharmaceuticals North America , Bridgewater, NJ , USA"},{"name":"LLC , Bridgewater, NJ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Kissling","sequence":"additional","affiliation":[{"name":"Valeant Pharmaceuticals North America , Bridgewater, NJ , USA"},{"name":"LLC , Bridgewater, NJ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2018,3,1]]},"reference":[{"key":"2023012309213674900_bib1","article-title":"Diagnostic and statistical manual of mental disorders","author":"American Psychiatric Association","year":"2000"},{"key":"2023012309213674900_bib2","doi-asserted-by":"crossref","first-page":"114","DOI":"10.1016\/j.mayocp.2016.09.018","article-title":"Hypoactive sexual desire disorder: International Society for the Study of Women\u2019s Sexual Health (ISSWSH) expert consensus panel review","volume":"92","author":"Goldstein","year":"2017","journal-title":"Mayo Clin Proc"},{"key":"2023012309213674900_bib3","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1097\/01.gme.0000172596.76272.06","article-title":"Hypoactive sexual desire disorder in postmenopausal women: US results from the Women\u2019s International Study of Health and Sexuality (WISHeS)","volume":"13","author":"Leiblum","year":"2006","journal-title":"Menopause"},{"key":"2023012309213674900_bib4","doi-asserted-by":"crossref","first-page":"970","DOI":"10.1097\/AOG.0b013e3181898cdb","article-title":"Sexual problems and distress in United States women: prevalence and correlates","volume":"112","author":"Shifren","year":"2008","journal-title":"Obstet Gynecol"},{"key":"2023012309213674900_bib5","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1089\/jwh.2011.3002","article-title":"Sexual desire problems in women seeking healthcare: a novel study design for ascertaining prevalence of hypoactive sexual desire disorder in clinic-based samples of U.S. women","volume":"21","author":"Rosen","year":"2012","journal-title":"J\u00a0Womens Health (Larchmt)"},{"key":"2023012309213674900_bib6","doi-asserted-by":"crossref","first-page":"817","DOI":"10.1089\/jwh.2014.4743","article-title":"Attitudinal survey of women living with low sexual desire","volume":"23","author":"Kingsberg","year":"2014","journal-title":"J\u00a0Womens Health (Larchmt)"},{"key":"2023012309213674900_bib7","article-title":"Addyi\u00ae (flibanserin) tablets, for oral use [package insert]","year":"2016"},{"key":"2023012309213674900_bib8","doi-asserted-by":"crossref","first-page":"915","DOI":"10.1007\/s40263-015-0288-1","article-title":"The female sexual response: current models, neurobiological underpinnings and agents currently approved or under investigation for the treatment of hypoactive sexual desire disorder","volume":"29","author":"Kingsberg","year":"2015","journal-title":"CNS Drugs"},{"key":"2023012309213674900_bib9","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1002\/phar.1209","article-title":"Hypoactive sexual desire disorder in women: treatment options beyond testosterone and approaches to communicating with patients on sexual health","volume":"33","author":"Lodise","year":"2013","journal-title":"Pharmacotherapy"},{"key":"2023012309213674900_bib10","first-page":"1074","article-title":"Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study","volume":"9","author":"DeRogatis","year":"2012","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib11","first-page":"793","article-title":"Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study","volume":"9","author":"Thorp","year":"2012","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib12","first-page":"1807","article-title":"Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial","volume":"10","author":"Katz","year":"2013","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib13","first-page":"3160","article-title":"Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): results from a randomized withdrawal trial","volume":"8","author":"Goldfischer","year":"2011","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib14","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1097\/GME.0000000000000134","article-title":"Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial","volume":"21","author":"Simon","year":"2014","journal-title":"Menopause"},{"key":"2023012309213674900_bib15","first-page":"2095","article-title":"Efficacy and safety of flibanserin in women with hypoactive sexual desire disorder: a systematic review and meta-analysis","volume":"12","author":"Gao","year":"2015","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib16","first-page":"3180","article-title":"Open-label extension study of flibanserin in women with hypoactive sexual desire disorder","volume":"9","author":"Jayne","year":"2012","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib17","first-page":"834","article-title":"Flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the PLUMERIA study","volume":"14","author":"Portman","year":"2017","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib18","first-page":"28","article-title":"The Clinical Global Impressions Scale: applying a research tool in clinical practice","volume":"4","author":"Busner","year":"2007","journal-title":"Psychiatry (Edgmont)"},{"key":"2023012309213674900_bib19","first-page":"357","article-title":"Validation of the Female Sexual Distress Scale\u2013Revised for assessing distress in women with hypoactive sexual desire disorder","volume":"5","author":"DeRogatis","year":"2008","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib20","first-page":"2237","article-title":"Content validity of the Female Sexual Function Index (FSFI) in pre- and postmenopausal women with hypoactive sexual desire disorder","volume":"8","author":"Revicki","year":"2011","journal-title":"J\u00a0Sex Med"},{"key":"2023012309213674900_bib21","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1080\/009262300278597","article-title":"The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function","volume":"26","author":"Rosen","year":"2000","journal-title":"J\u00a0Sex Marital Ther"},{"key":"2023012309213674900_bib22","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/00926230590475206","article-title":"The Female Sexual Function Index (FSFI): cross-validation and development of clinical cutoff scores","volume":"31","author":"Wiegel","year":"2005","journal-title":"J\u00a0Sex Marital Ther"},{"key":"2023012309213674900_bib23","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1001\/jamainternmed.2015.8565","article-title":"Efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women: a systematic review and meta-analysis","volume":"176","author":"Jaspers","year":"2016","journal-title":"JAMA Intern Med"},{"key":"2023012309213674900_bib24","doi-asserted-by":"crossref","first-page":"41","DOI":"10.15585\/mmwr.mm6503a1","article-title":"Antidepressant prescription claims among reproductive-aged women with private employer-sponsored insurance\u2014United States 2008\u20132013","volume":"65","author":"Dawson","year":"2016","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2023012309213674900_bib25","article-title":"Zoloft\u00ae (sertraline hydrochloride) tablets, for oral use; Zoloft\u00ae (sertraline hydrochloride) oral concentrate; Zoloft\u00ae (sertraline hydrochloride) oral solution [package insert]","year":"2017"},{"key":"2023012309213674900_bib26","article-title":"Wellbutrin\u00ae (bupropion hydrochloride) tablets, for oral use [package insert]","year":"2017"},{"key":"2023012309213674900_bib27","article-title":"Celexa\u00ae (citalopram hydrobromide) tablets\/oral solution [package insert]","year":"2011"},{"key":"2023012309213674900_bib28","article-title":"Lexapro\u00ae (escitalopram oxalate) tablets Lexapro\u00ae (escitalopram oxalate) oral solution [package insert]","year":"2017"},{"key":"2023012309213674900_bib29","article-title":"Prozac\u00ae (fluoxetine hydrochloride) for oral use Prozac (fluoxetine hydrochloride) delayed-release capsules for oral use [package insert]","year":"2017"},{"key":"2023012309213674900_bib30","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1111\/jcpt.12563","article-title":"The pharmacodynamic effects of combined administration of flibanserin and alcohol","volume":"42","author":"Stevens","year":"2017","journal-title":"J\u00a0Clin Pharm Ther"},{"key":"2023012309213674900_bib31","doi-asserted-by":"crossref","DOI":"10.1016\/j.jsxm.2017.04.569","article-title":"Effect of alcohol administered with flibanserin on dizziness, syncope, and hypotension in healthy, premenopausal women","author":"Sicard","year":"2017"},{"key":"2023012309213674900_bib32","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1056\/NEJMp1513686","article-title":"FDA approval of flibanserin\u2014treating hypoactive sexual desire disorder","volume":"374","author":"Joffe","year":"2016","journal-title":"N\u00a0Engl\u00a0J Med"}],"container-title":["The Journal of Sexual Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1743609518300067?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1743609518300067?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/academic.oup.com\/jsm\/article-pdf\/15\/3\/387\/48587200\/jsm_15_3_387.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jsm\/article-pdf\/15\/3\/387\/48587200\/jsm_15_3_387.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T09:44:16Z","timestamp":1674467056000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jsm\/article\/15\/3\/387\/6980267"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,1]]},"references-count":32,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2018,3,1]]},"published-print":{"date-parts":[[2018,3,1]]}},"URL":"https:\/\/doi.org\/10.1016\/j.jsxm.2017.12.016","relation":{},"ISSN":["1743-6109","1743-6095"],"issn-type":[{"value":"1743-6109","type":"electronic"},{"value":"1743-6095","type":"print"}],"subject":[],"published-other":{"date-parts":[[2018,3]]},"published":{"date-parts":[[2018,3,1]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study","name":"articletitle","label":"Article Title"},{"value":"The Journal of Sexual Medicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jsxm.2017.12.016","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2018 International Society for Sexual Medicine. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}]}}