title: Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study.
abstract: BACKGROUND
  Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty.
  
  
  OBJECTIVE
  To assess the efficacy and tolerability of flibanserin, a postsynaptic 5-HT1A agonist/5-HT2A antagonist, in the treatment of premenopausal women with HSDD.
  
  
  METHODS
  North American premenopausal women with HSDD (mean age 35 years) were randomized to 24 weeks' treatment with flibanserin 25 mg twice daily (N=396), 50 mg twice daily (N=392), 100 mg once daily at bedtime (N=395), or placebo (N=398).
  
  
  METHODS
  Co-primary endpoints were changed from baseline to study end in number of satisfying sexual events (SSE) and sexual desire score, measured daily using an eDiary. Secondary endpoints included change in Female Sexual Distress Scale-Revised (FSDS-R) total score and Item 13 score (distress due to low sexual desire), Female Sexual Function Index (FSFI) total and desire domain scores, and Patient's Global Impression of Improvement.
  
  
  RESULTS
  Flibanserin 100 mg once daily was associated with an increase in SSE (P<0.01 vs. placebo) but the 25 mg and 50 mg twice daily doses were not. No group showed a significant increase in eDiary desire score vs. placebo. All flibanserin regimens improved FSDS-R total, FSDS-R Item 13, FSFI total, and FSFI desire domain scores vs. placebo (P<0.05, for all). More women receiving flibanserin 50 mg twice daily and 100 mg once daily considered their HSDD to have improved than women receiving placebo (44.1% and 47.0% vs. 30.3%, respectively) (P<0.000, 1 vs. placebo). The most frequently reported adverse events in women receiving flibanserin were somnolence (11.8%), dizziness (10.5%), and fatigue (10.3%).
  
  
  CONCLUSIONS
  In premenopausal women with HSDD, flibanserin 100 mg once daily was well tolerated and associated with statistically significant improvements in SSE, sexual desire (FSFI desire domain score but not eDiary desire score), sexual function, and decrease in sexual distress vs. placebo.
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7570, USA. john_thorp@med.unc.edu
authors.forename: John
authors.initials: J
authors.lastname: Thorp
authors.forename: James
authors.initials: J
authors.lastname: Simon
authors.forename: Dan
authors.initials: D
authors.lastname: Dattani
authors.forename: Leslie
authors.initials: L
authors.lastname: Taylor
authors.forename: Toshio
authors.initials: T
authors.lastname: Kimura
authors.forename: Miguel
authors.initials: M
authors.lastname: Garcia
authors.forename: Lynna
authors.initials: L
authors.lastname: Lesko
authors.forename: Robert
authors.initials: R
authors.lastname: Pyke
mesh_terms: D000328:Adult; D001562:Benzimidazoles / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017697:Premenopause; D018490:Serotonin Agents / Q000627:therapeutic use*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D001562:Benzimidazoles; D018490:Serotonin Agents; C098107:flibanserin