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Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study.

Abstract

INTRODUCTION

Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty.

AIM

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).

MAIN OUTCOME MEASURES

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%).

CONCLUSION

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.

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  • Publisher Full Text
  • Authors

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    Source

    The journal of sexual medicine 9:3 2012 Mar pg 793-804

    MeSH

    Adult
    Benzimidazoles
    Female
    Humans
    Premenopause
    Serotonin Agents
    Sexual Dysfunctions, Psychological
    Treatment Outcome

    Pub Type(s)

    Clinical Trial, Phase III
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22239862

    Citation

    TY - JOUR T1 - Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. AU - Thorp,John, AU - Simon,James, AU - Dattani,Dan, AU - Taylor,Leslie, AU - Kimura,Toshio, AU - Garcia,Miguel,Jr AU - Lesko,Lynna, AU - Pyke,Robert, AU - ,, Y1 - 2012/01/12/ PY - 2012/1/12/aheadofprint PY - 2012/1/14/entrez PY - 2012/1/14/pubmed PY - 2012/6/19/medline SP - 793 EP - 804 JF - The journal of sexual medicine JO - J Sex Med VL - 9 IS - 3 N2 - INTRODUCTION: Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty. AIM: 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). MAIN OUTCOME MEASURES: 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%). CONCLUSION: 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. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/22239862/Treatment_of_hypoactive_sexual_desire_disorder_in_premenopausal_women:_efficacy_of_flibanserin_in_the_DAISY_study_ L2 - http://dx.doi.org/10.1111/j.1743-6109.2011.02595.x ER -