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.

• Authors: Molly Katz, Leonard R DeRogatis, Ronald Ackerman, Parke Hedges, Lynna Lesko, Miguel Garcia Jr, Michael Sand, BEGONIA trial investigators
• Journal: The journal of sexual medicine (J Sex Med) Vol. 10 Issue 7 Pg. 1807-15 (Jul 2013) ISSN: 1743-6109 [Electronic] Netherlands
• PMID: 23672269 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 International Society for Sexual Medicine.

Chemical References

• Benzimidazoles
• Placebos
• Serotonin 5-HT1 Receptor Agonists
• Serotonin 5-HT2 Receptor Antagonists
• flibanserin

Topics

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