Open-Label Extension Study of Flibanserin in Women with Hypoactive Sexual Desire Disorder

Abstract

Introduction Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female Sexual Dysfunction characterized by low sexual desire that causes distress or interpersonal difficulty. Aim This 52‐week open‐label extension study aimed to assess the safety and tolerability of flibanserin, a postsynaptic 5‐HT_1A agonist/5‐HT_2A antagonist, in women with HSDD. Methods Women with HSDD who had completed a trial of flibanserin or flibanserin placebo received flexible‐dose flibanserin (50 or 100 mg once daily at bedtime [qhs] or 25 or 50 mg twice daily [bid]) for 52 weeks. Main Outcome Measures Primary end points were: proportions of women with somnolence, sedation, fatigue, dizziness, nausea, and vomiting (adverse events [AEs] known to be associated with flibanserin); discontinuations due to AEs; and serious AEs. Secondary end points included change from baseline in Female Sexual Distress Scale‐Revised total and Item 13 scores and Female Sexual Function Index (FSFI) total and desire domain score scores. FSFI total scores were used to classify women into FSFI remitters (FSFI score >26.55, indicating no clinical sexual dysfunction) and FSFI non‐remitters (FSFI score Jayne C, Simon JA, Taylor LV, Kimura T, and Lesko LM. Open‐label extension study of flibanserin in women with Hypoactive Sexual Desire Disorder. J Sex Med 2012;9:3180–3188.