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Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial.

Abstract

INTRODUCTION

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

AIM

The aim of this study was to assess the efficacy and safety of the 5-HT1A agonist/5-HT2A antagonist flibanserin in premenopausal women with HSDD.

METHODS

This was a randomized, placebo-controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime (qhs) (n = 542) or placebo (n = 545) for 24 weeks.

MAIN OUTCOME MEASURES

Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and FSDS-R Item 13 score.

RESULTS

Compared with placebo, flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS-R Item 13 score of -1.0 (0.1) vs. -0.7 (0.1) and mean (SE) FSDS-R total score of -9.4 (0.6) vs. -6.1 (0.6); all P ≤ 0.0001. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo.

CONCLUSION

In premenopausal women with HSDD, flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS-R total score) and distress associated with low sexual desire (FSDS-R Item 13) vs. placebo. There were no significant safety concerns associated with the use of flibanserin for 24 weeks.

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  • Authors+Show Affiliations

    ,

    Katz and Kade, Cincinnati, OH 45219, USA. mollykatz5@gmail.com

    , , , , , ,

    Source

    The journal of sexual medicine 10:7 2013 Jul pg 1807-15

    MeSH

    Adult
    Aged
    Benzimidazoles
    Dizziness
    Double-Blind Method
    Female
    Humans
    Libido
    Middle Aged
    Motivation
    Nausea
    Outcome Assessment (Health Care)
    Personal Satisfaction
    Placebos
    Premenopause
    Serotonin 5-HT1 Receptor Agonists
    Serotonin 5-HT2 Receptor Antagonists
    Sexual Behavior
    Sexual Dysfunctions, Psychological

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    23672269

    Citation

    Katz, Molly, et al. "Efficacy of Flibanserin in Women With Hypoactive Sexual Desire Disorder: Results From the BEGONIA Trial." The Journal of Sexual Medicine, vol. 10, no. 7, 2013, pp. 1807-15.
    Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med. 2013;10(7):1807-15.
    Katz, M., DeRogatis, L. R., Ackerman, R., Hedges, P., Lesko, L., Garcia, M., & Sand, M. (2013). Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. The Journal of Sexual Medicine, 10(7), pp. 1807-15. doi:10.1111/jsm.12189.
    Katz M, et al. Efficacy of Flibanserin in Women With Hypoactive Sexual Desire Disorder: Results From the BEGONIA Trial. J Sex Med. 2013;10(7):1807-15. PubMed PMID: 23672269.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. AU - Katz,Molly, AU - DeRogatis,Leonard R, AU - Ackerman,Ronald, AU - Hedges,Parke, AU - Lesko,Lynna, AU - Garcia,Miguel,Jr AU - Sand,Michael, AU - ,, Y1 - 2013/05/14/ PY - 2013/5/16/entrez PY - 2013/5/16/pubmed PY - 2014/6/27/medline KW - Distress KW - Flibanserin KW - HSDD KW - Hypoactive Sexual Desire Disorder KW - Patient-Reported Outcomes KW - Premenopausal Women SP - 1807 EP - 15 JF - The journal of sexual medicine JO - J Sex Med VL - 10 IS - 7 N2 - INTRODUCTION: Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty. AIM: The aim of this study was to assess the efficacy and safety of the 5-HT1A agonist/5-HT2A antagonist flibanserin in premenopausal women with HSDD. METHODS: This was a randomized, placebo-controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime (qhs) (n = 542) or placebo (n = 545) for 24 weeks. MAIN OUTCOME MEASURES: Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and FSDS-R Item 13 score. RESULTS: Compared with placebo, flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS-R Item 13 score of -1.0 (0.1) vs. -0.7 (0.1) and mean (SE) FSDS-R total score of -9.4 (0.6) vs. -6.1 (0.6); all P ≤ 0.0001. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo. CONCLUSION: In premenopausal women with HSDD, flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS-R total score) and distress associated with low sexual desire (FSDS-R Item 13) vs. placebo. There were no significant safety concerns associated with the use of flibanserin for 24 weeks. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/23672269/Efficacy_of_flibanserin_in_women_with_hypoactive_sexual_desire_disorder:_results_from_the_BEGONIA_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)30413-6 DB - PRIME DP - Unbound Medicine ER -