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Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study.

Abstract

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-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.

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 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).

CONCLUSION

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.

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  • Authors+Show Affiliations

    ,

    The Center for Sexual Medicine at Sheppard Pratt, Johns Hopkins Department of Psychiatry and Behavioural Sciences, Baltimore, MD 21285-6815, USA. lderogatis@sheppardpratt.org

    , , , , , , ,

    Source

    The journal of sexual medicine 9:4 2012 Apr pg 1074-85

    MeSH

    Benzimidazoles
    Canada
    Cerebral Cortex
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Libido
    Premenopause
    Serotonin Agents
    Sexual Behavior
    Sexual Dysfunctions, Psychological
    Surveys and Questionnaires
    United States

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22248038

    Citation

    Derogatis, Leonard R., et al. "Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study." The Journal of Sexual Medicine, vol. 9, no. 4, 2012, pp. 1074-85.
    Derogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012;9(4):1074-85.
    Derogatis, L. R., Komer, L., Katz, M., Moreau, M., Kimura, T., Garcia, M., ... Pyke, R. (2012). Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. The Journal of Sexual Medicine, 9(4), pp. 1074-85. doi:10.1111/j.1743-6109.2011.02626.x.
    Derogatis LR, et al. Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study. J Sex Med. 2012;9(4):1074-85. PubMed PMID: 22248038.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. AU - Derogatis,Leonard R, AU - Komer,Lawrence, AU - Katz,Molly, AU - Moreau,Michèle, AU - Kimura,Toshio, AU - Garcia,Miguel,Jr AU - Wunderlich,Glen, AU - Pyke,Robert, AU - ,, Y1 - 2012/01/16/ PY - 2012/1/18/entrez PY - 2012/1/18/pubmed PY - 2012/8/16/medline SP - 1074 EP - 85 JF - The journal of sexual medicine JO - J Sex Med VL - 9 IS - 4 N2 - 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-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. 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 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). CONCLUSION: 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. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/22248038/Treatment_of_hypoactive_sexual_desire_disorder_in_premenopausal_women:_efficacy_of_flibanserin_in_the_VIOLET_Study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33935-7 DB - PRIME DP - Unbound Medicine ER -