TY - JOUR
T1 - Efficacy of flibanserin in women with hypoactive sexual desire disorder
T2 - Results from the BEGONIA trial
AU - Katz, Molly
AU - Derogatis, Leonard R.
AU - Ackerman, Ronald
AU - Hedges, Parke
AU - Lesko, Lynna
AU - Garcia, Miguel
AU - Sand, Michael
N1 - Funding Information:
The study reported in this manuscript was funded by the previous owner of the flibanserin program and initiator of the study, Boehringer Ingelheim (ClinicalTrials.gov registry number: NCT00996164). Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Lindsay Napier PhD, and Wendy Morris, MSc, of Fleishman‐Hillard Group Limited, London, UK, during the preparation of this manuscript. The authors were responsible for all content and editorial decisions, were involved at all stages of manuscript development, and have approved the final version. The authors acknowledge the contribution of Robert Pyke, MD, PhD, formerly of Boehringer Ingelheim, to the design of the study, interpretation of results, and earlier drafts of this manuscript. Sprout Pharmaceuticals, Inc. has acquired flibanserin and is now fully responsible for future development.
PY - 2013/7
Y1 - 2013/7
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 100mg 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 100mg 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.
AB - 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 100mg 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 100mg 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.
KW - Distress
KW - Flibanserin
KW - HSDD
KW - Hypoactive Sexual Desire Disorder
KW - Patient-Reported Outcomes
KW - Premenopausal Women
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U2 - 10.1111/jsm.12189
DO - 10.1111/jsm.12189
M3 - Article
C2 - 23672269
AN - SCOPUS:84879838857
SN - 1743-6095
VL - 10
SP - 1807
EP - 1815
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 7
ER -