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.

Effects of methylphenidate and MDMA on appraisal of erotic stimuli and intimate relationships

“…Accordingly, the DA and NE transporter inhibitor and antidepressant bupropion, which has less side effects on sexual arousal and libido than serotonergic antidepressants, increased activation of brain regions related to sexual functioning (Abler et al, 2011). Moreover, flibanserin, which enhances NE and DA while reducing 5-HT (Borsini et al, 2002), increased sexual desire in women with hypoactive sexual desire (Katz et al, 2013). Finally, dextroamphetamine and methylphenidate have been reported to reverse the sexually impairing effects of 5-HT transporter blockers and to even enhance sexual arousal and function in female and male patients with depression (Bartlik et al, 1995).…”

Sexual Health as a Survivorship Issue for Female Cancer Survivors

“…Other endocrine therapies under investigation include intravaginal preparations of dehydroepiandrosterone, which aims to enhance local sex steroid concentrations with minimal increases in systemic concentrations of estradiol or testosterone [70], and the 5-hydroxytryptamine 1A receptor inhibitor flibanserin [71]. Further evaluations of these agents are required to understand their efficacy and safety in these patients.…”

Flibanserin: First Global Approval

“…The findings of VIOLET and DAISY were subsequently supported by another 24-week phase III trial, BEGONIA (NCT00996164) [29]. By the end of this study, flibanserin 100 mg once daily at bedtime had significantly (p \ 0.001 vs. placebo) improved both the SSE number (adjusted mean changes from baseline were 2.5 vs. 1.5 with placebo) and the sexual desire (adjusted mean changes from baseline in FSFI desire domain score were 1.0 vs. 0.7) experienced over 4 weeks by premenopausal women with HSDD (coprimary endpoints).…”