Continued Efficacy and Safety of Flibanserin in Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD): Results from a Randomized Withdrawal Trial
- 1 November 2011
- journal article
- research article
- Published by Oxford University Press (OUP) in The Journal of Sexual Medicine
- Vol. 8 (11), 3160-3172
- https://doi.org/10.1111/j.1743-6109.2011.02458.x
Abstract
Flibanserin is a 5‐HT1A agonist/5‐HT2A antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD). To assess the efficacy and safety of flibanserin over 24 weeks of double‐blind treatment vs. placebo in premenopausal women with HSDD who showed a predefined response after 24 weeks of open‐label treatment with flibanserin. Women (N = 738) were treated with open‐label, flexible‐dose flibanserin (50 mg or 100 mg/day) for 24 weeks. At week 24, women who showed a predefined response, measured using an eDiary, were randomized to 24 weeks of continued flibanserin therapy at optimized dosage (N = 163) or placebo (N = 170). The criteria for entering the double‐blind phase were an increase from baseline to weeks 21–24 of ≥2 satisfying sexual events (SSE) and/or ≥4 “desire days.” A “desire day” was one in which a woman reported more than “no” desire. Coprimary endpoints were change from randomization to study end in SSE and desire score. Secondary measures included change in Female Sexual Function Index (FSFI) total and desire domain scores and Female Sexual Distress Scale‐Revised (FSDS‐R) total and Item 13 scores. During the open‐label period, mean SSE and desire score approximately doubled, and FSFI, FSDS‐R total, and Item 13 scores improved. At the end of the double‐blind period, flibanserin was superior to placebo in change from randomization in SSE, desire score, FSFI desire domain and total scores, and FSDS‐R total and Item 13 scores (P < 0.05, for all). Flibanserin was well tolerated, and withdrawal reactions were not observed. old> At the end of the 24‐week randomized withdrawal phase of a 48‐week trial in premenopausal women with HSDD, flibanserin was superior to placebo on measures of SSE, sexual desire, overall sexual function, and sexual distress. Flibanserin was well tolerated, and no withdrawal reactions were observed following discontinuation. Goldfischer ER, Breaux J, Katz M, Kaufman J, Smith WB, Kimura T, Sand M, and Pyke R. Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): Results from a randomized withdrawal trial. J Sex Med 2011;8:3160–3170.Keywords
This publication has 20 references indexed in Scilit:
- Content Validity of the Female Sexual Function Index (FSFI) in Pre- and Postmenopausal Women with Hypoactive Sexual Desire DisorderThe Journal of Sexual Medicine, 2011
- Multifunctional Pharmacology of Flibanserin: Possible Mechanism of Therapeutic Action in Hypoactive Sexual Desire DisorderThe Journal of Sexual Medicine, 2011
- Sexual Desire and the Female Sexual Function Index (FSFI): A Sexual Desire Cutpoint for Clinical Interpretation of the FSFI in Women with and without Hypoactive Sexual Desire DisorderThe Journal of Sexual Medicine, 2010
- Management of Female Sexual Problems: Perceived Barriers, Practice Patterns, and Confidence among Primary Care Physicians and GynecologistsThe Journal of Sexual Medicine, 2010
- ORIGINAL RESEARCH—BASIC SCIENCE: Acute and Repeated Flibanserin Administration in Female Rats Modulates Monoamines Differentially Across Brain Areas: A Microdialysis StudyThe Journal of Sexual Medicine, 2010
- Correlates of Sexually Related Personal Distress in Women with Low Sexual DesireThe Journal of Sexual Medicine, 2009
- Validation of the Female Sexual Distress Scale-Revised for Assessing Distress in Women with Hypoactive Sexual Desire DisorderThe Journal of Sexual Medicine, 2008
- Female Sexuality and Sexual Dysfunction: Are We Stuck on the Learning Curve?The Journal of Sexual Medicine, 2006
- Pharmacology of FlibanserinCNS Drug Reviews, 2002
- Executive summary: Stages of Reproductive Aging Workshop (STRAW)Climacteric, 2001