Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The Female Sexual Function Index (FSFI) is a validated self-report questionnaire comprising 6 domains of sexual functioning: desire, arousal, lubrication, orgasm, satisfaction, and pain. This post hoc analysis evaluated the effect of flibanserin treatment across the 6 FSFI domains.
Patient-level data were pooled from three 24-week, double-blind, placebo-controlled studies of flibanserin 100 mg once daily (qhs) in premenopausal women with HSDD. Between group differences in change from baseline to week 24 (last observation carried forward [LOCF]) on FSFI domain and total scores were evaluated using analysis of covariance.
This analysis included 2368 women (flibanserin, n=1165; placebo, n=1204) who had at least one on-treatment efficacy assessment. The least-squares mean differences (standard error of the mean) in change scores from baseline to week 24 (LOCF) for flibanserin versus placebo were 0.3 (0.1) for the FSFI desire domain, 0.4 (0.1) for the arousal domain, 0.3 (0.1) for the lubrication domain, 0.3 (0.1) for the orgasm domain, 0.3 (0.1) for the satisfaction domain, 0.2 (0.1) for the pain domain, and 1.9 (0.3) for the total score; all P less than 0.0001 except P less than 0.01 for pain.
Treatment with flibanserin produced significant improvement not only in the FSFI desire domain (a key outcome in clinical trials of HSDD) but also across the other domains of sexual function assessed by the FSFI.