Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study

Leonard R. Derogatis, Lawrence Komer, Molly Katz, Michèle Moreau, Toshio Kimura, Miguel Garcia, Glen Wunderlich, Robert Pyke

Research output: Contribution to journalArticlepeer-review


Introduction. Hypoactive Sexual Desire Disorder (HSDD) is the most common form of Female Sexual Dysfunction and is characterized by low sexual desire that causes distress. Aim. The aim of this study was to assess the efficacy and safety of flibanserin, a postsynaptic 5-HT1A agonist/5-HT2A antagonist, in premenopausal women with HSDD. Methods. North American premenopausal women with HSDD were randomized to 24 weeks' treatment with placebo (N=295), flibanserin 50mg (N=295), or flibanserin 100mg (N=290), once daily at bedtime. Main Outcome Measures. 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 50mg and 100mg 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 100mg, 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 100mg (P<0.001), indicating reduced sexual distress. More women receiving flibanserin 50mg and 100mg considered their HSDD to have improved than women receiving placebo (39.6% and 50.0% vs. 30.3%, respectively) (P<0.05). Conclusion. In premenopausal women with HSDD, flibanserin 50mg and 100mg 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.

Original languageEnglish (US)
Pages (from-to)1074-1085
Number of pages12
JournalJournal of Sexual Medicine
Issue number4
StatePublished - Apr 2012


  • Distress
  • Flibanserin
  • HSDD
  • Hypoactive sexual desire disorder
  • PRO
  • Patient-reported outcomes
  • Premenopausal women

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology


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