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Open-label extension study of flibanserin in women with hypoactive sexual desire disorder.

Abstract

INTRODUCTION

Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female Sexual Dysfunction characterized by low sexual desire that causes distress or interpersonal difficulty.

AIM

This 52-week open-label extension study aimed to assess the safety and tolerability of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, in women with HSDD.

METHODS

Women with HSDD who had completed a trial of flibanserin or flibanserin placebo received flexible-dose flibanserin (50 or 100 mg once daily at bedtime [qhs] or 25 or 50 mg twice daily [bid]) for 52 weeks.

MAIN OUTCOME MEASURES

Primary end points were: proportions of women with somnolence, sedation, fatigue, dizziness, nausea, and vomiting (adverse events [AEs] known to be associated with flibanserin); discontinuations due to AEs; and serious AEs. Secondary end points included change from baseline in Female Sexual Distress Scale-Revised total and Item 13 scores and Female Sexual Function Index (FSFI) total and desire domain score scores. FSFI total scores were used to classify women into FSFI remitters (FSFI score >26.55, indicating no clinical sexual dysfunction) and FSFI non-remitters (FSFI score <26.55).

RESULTS

Of the 1723 women who received flibanserin, 962 (55.8%) completed 12 months' treatment, and 883 women were exposed to flibanserin 100 mg qhs for ≥180 days. Somnolence, sedation, fatigue, dizziness, nausea, and vomiting were reported by 15.8, 1.6, 7.6, 6.9, 6.3, and 1.4% of participants, respectively. A total of 185 participants (10.7%) discontinued due to AEs. Serious AEs were reported by 1.2% of participants. At study end, 42% of baseline non-remitters had improved their FSFI score to remission level. The proportion of baseline FSFI remitters in remission rose from 83% at week 4 to a stable value of ∼90%.

CONCLUSION

Flibanserin was well tolerated. Sexual function improved in women who were not FSFI remitters at baseline, and was maintained in those who were remitters at baseline.

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  • Authors+Show Affiliations

    ,

    Scott Department of Urology, Baylor College of Medicine, Houston, TX 77030, USA. chrisjayne41@yahoo.com

    , , , ,

    Source

    The journal of sexual medicine 9:12 2012 Dec pg 3180-8

    MeSH

    Adolescent
    Adult
    Benzimidazoles
    Dizziness
    Dose-Response Relationship, Drug
    Drug Administration Schedule
    Fatigue
    Female
    Humans
    Middle Aged
    Nausea
    Serotonin Agents
    Sexual Dysfunctions, Psychological
    Vomiting
    Young Adult

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    23057791

    Citation

    Jayne, Christopher, et al. "Open-label Extension Study of Flibanserin in Women With Hypoactive Sexual Desire Disorder." The Journal of Sexual Medicine, vol. 9, no. 12, 2012, pp. 3180-8.
    Jayne C, Simon JA, Taylor LV, et al. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012;9(12):3180-8.
    Jayne, C., Simon, J. A., Taylor, L. V., Kimura, T., & Lesko, L. M. (2012). Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. The Journal of Sexual Medicine, 9(12), pp. 3180-8. doi:10.1111/j.1743-6109.2012.02942.x.
    Jayne C, et al. Open-label Extension Study of Flibanserin in Women With Hypoactive Sexual Desire Disorder. J Sex Med. 2012;9(12):3180-8. PubMed PMID: 23057791.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. AU - Jayne,Christopher, AU - Simon,James A, AU - Taylor,Leslie V, AU - Kimura,Toshio, AU - Lesko,Lynna M, AU - ,, Y1 - 2012/10/11/ PY - 2012/10/13/entrez PY - 2012/10/13/pubmed PY - 2013/5/28/medline SP - 3180 EP - 8 JF - The journal of sexual medicine JO - J Sex Med VL - 9 IS - 12 N2 - INTRODUCTION: Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female Sexual Dysfunction characterized by low sexual desire that causes distress or interpersonal difficulty. AIM: This 52-week open-label extension study aimed to assess the safety and tolerability of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, in women with HSDD. METHODS: Women with HSDD who had completed a trial of flibanserin or flibanserin placebo received flexible-dose flibanserin (50 or 100 mg once daily at bedtime [qhs] or 25 or 50 mg twice daily [bid]) for 52 weeks. MAIN OUTCOME MEASURES: Primary end points were: proportions of women with somnolence, sedation, fatigue, dizziness, nausea, and vomiting (adverse events [AEs] known to be associated with flibanserin); discontinuations due to AEs; and serious AEs. Secondary end points included change from baseline in Female Sexual Distress Scale-Revised total and Item 13 scores and Female Sexual Function Index (FSFI) total and desire domain score scores. FSFI total scores were used to classify women into FSFI remitters (FSFI score >26.55, indicating no clinical sexual dysfunction) and FSFI non-remitters (FSFI score <26.55). RESULTS: Of the 1723 women who received flibanserin, 962 (55.8%) completed 12 months' treatment, and 883 women were exposed to flibanserin 100 mg qhs for ≥180 days. Somnolence, sedation, fatigue, dizziness, nausea, and vomiting were reported by 15.8, 1.6, 7.6, 6.9, 6.3, and 1.4% of participants, respectively. A total of 185 participants (10.7%) discontinued due to AEs. Serious AEs were reported by 1.2% of participants. At study end, 42% of baseline non-remitters had improved their FSFI score to remission level. The proportion of baseline FSFI remitters in remission rose from 83% at week 4 to a stable value of ∼90%. CONCLUSION: Flibanserin was well tolerated. Sexual function improved in women who were not FSFI remitters at baseline, and was maintained in those who were remitters at baseline. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/23057791/Open_label_extension_study_of_flibanserin_in_women_with_hypoactive_sexual_desire_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33815-7 DB - PRIME DP - Unbound Medicine ER -