title: Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study.
abstract: BACKGROUND
  Hypoactive sexual desire disorder (HSDD) is the most common form of female sexual dysfunction and is characterized by low sexual desire that causes distress.
  
  
  OBJECTIVE
  The aim of this study was to assess the efficacy and safety of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, in premenopausal women with HSDD.
  
  
  METHODS
  North American premenopausal women with HSDD were randomized to 24 weeks' treatment with placebo (N = 295), flibanserin 50 mg (N = 295), or flibanserin 100 mg (N = 290), once daily at bedtime.
  
  
  METHODS
  Coprimary endpoints were change from baseline to study end in number of satisfying sexual events (SSE) and sexual desire score measured daily using an electronic diary (eDiary). Secondary endpoints included change from baseline to study end in female sexual function index (FSFI) desire domain and total scores, female sexual distress scale-revised (FSDS-R) Item 13 and total scores, and patient's global impression of improvement.
  
  
  RESULTS
  Flibanserin 50 mg and 100 mg led to increases in SSE (P < 0.05 and P < 0.01 vs. placebo, respectively). There was a numerical trend toward improvement in eDiary desire score on flibanserin 100 mg, but statistical significance was not reached (P = 0.07 vs. placebo). FSFI desire domain and total scores increased with both flibanserin regimens (P < 0.05). FSDS-R total and Item 13 scores decreased with flibanserin 100 mg (P < 0.001), indicating reduced sexual distress. More women receiving flibanserin 50 mg and 100 mg considered their HSDD to have improved than women receiving placebo (39.6% and 50.0% vs. 30.3%, respectively) (P < 0.05).
  
  
  CONCLUSIONS
  In premenopausal women with HSDD, flibanserin 50 mg and 100 mg once daily at bedtime were well tolerated and associated with statistically significant improvements in SSE, sexual desire (FSFI desire domain score but not eDiary desire score) and overall sexual function, and reduction of sexual distress, vs. placebo.
authors.affiliation: The Center for Sexual Medicine at Sheppard Pratt, Johns Hopkins Department of Psychiatry and Behavioural Sciences, Baltimore, MD 21285-6815, USA. lderogatis@sheppardpratt.org
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Derogatis
authors.forename: Lawrence
authors.initials: L
authors.lastname: Komer
authors.forename: Molly
authors.initials: M
authors.lastname: Katz
authors.forename: Michèle
authors.initials: M
authors.lastname: Moreau
authors.forename: Toshio
authors.initials: T
authors.lastname: Kimura
authors.forename: Miguel
authors.initials: M
authors.lastname: Garcia
authors.forename: Glen
authors.initials: G
authors.lastname: Wunderlich
authors.forename: Robert
authors.initials: R
authors.lastname: Pyke
mesh_terms: D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002540:Cerebral Cortex / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007989:Libido / Q000187:drug effects; D017697:Premenopause; D018490:Serotonin Agents / Q000009:adverse effects / Q000627:therapeutic use*; D012725:Sexual Behavior / Q000187:drug effects; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D001562:Benzimidazoles; D018490:Serotonin Agents; C098107:flibanserin