2012
DOI: 10.1111/j.1743-6109.2011.02626.x
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Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study

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Cited by 140 publications
(133 citation statements)
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“…Similar benefits were observed with flibanserin in this setting in a smaller phase III study known as VIOLET (NCT00360529) [28]. Relative to placebo, flibanserin 50 or 100 mg once daily at bedtime significantly (p \ 0.05) improved the number of SSEs (mean changes from baseline were 1.4 and 1.6 vs. 0.8 with placebo), but not sexual desire measured by eDiary score (mean changes from baseline were 8.2 and 9.1 vs. 6.9) over 24 weeks of therapy (coprimary endpoints).…”
Section: Premenopausal Women With Hsddsupporting
confidence: 68%
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“…Similar benefits were observed with flibanserin in this setting in a smaller phase III study known as VIOLET (NCT00360529) [28]. Relative to placebo, flibanserin 50 or 100 mg once daily at bedtime significantly (p \ 0.05) improved the number of SSEs (mean changes from baseline were 1.4 and 1.6 vs. 0.8 with placebo), but not sexual desire measured by eDiary score (mean changes from baseline were 8.2 and 9.1 vs. 6.9) over 24 weeks of therapy (coprimary endpoints).…”
Section: Premenopausal Women With Hsddsupporting
confidence: 68%
“…However, other measures of sexual desire (FSFI desire domain scores), as well as overall sexual function (FSFI total score), were significantly (p \ 0.05 vs. placebo) improved with each of the flibanserin dosages. Flibanserin 100 mg, but not 50 mg, once daily also significantly (p \ 0.001) reduced the distress associated with sexual dysfunction and low sexual desire (measured by the total score and item 13 score of the FSDS-R) [28]. This study was of double-blind design and randomized 880 North American premenopausal women with HSDD.…”
Section: Premenopausal Women With Hsddmentioning
confidence: 96%
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“…Flibanserin, a drug purportedly acting as a 5-HT 1A receptor agonist and 5-HT 2A receptor antagonist, has been shown to increase paracopulatory behavior in female rats (Gelez et al, 2013) and it has been reported to have weak stimulatory effects on sexual motivation in women (DeRogatis et al, 2012;Thorp et al, 2012). These observations suggest that effects on paracopulatory behavior in rats indeed coincide with clinical effects in women.…”
Section: Paracopulatory Behavior As Indicator Of Female Sexual Motivamentioning
confidence: 79%
“…In the first two trials abbreviated as DAISY and VIOLET, flibanserin was found to have significant improvement in the number of sexually satisfying events, albeit with a marginal magnitude. 8,9 There was also improvement in other secondary end points such as FSFI, FSDS and item-13 scores. However the sexual desire score as assessed by eDiary score which was one of the co-primary end points did not reach statistical significance.…”
Section: Efficacymentioning
confidence: 95%