OBJECTIVE: This study aimed to assess the efficacy and safety of flibanserin, a 
serotonin receptor 1A agonist/serotonin receptor 2A antagonist, in 
postmenopausal women with hypoactive sexual desire disorder (HSDD).
METHODS: Naturally postmenopausal women with HSDD received flibanserin 100 mg 
once daily at bedtime (n = 468) or placebo (n = 481) for 24 weeks. Co-primary 
endpoints were changes from baseline to week 24 in the number of satisfying 
sexual events (SSEs) across 28 days and in the Female Sexual Function Index 
(FSFI) desire domain score. Secondary endpoints included change from baseline in 
Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (which assesses 
distress due to low sexual desire), FSDS-R total score, and FSFI total score. 
The Patient Benefit Evaluation was asked on treatment discontinuation.
RESULTS: There were significant improvements with flibanserin versus placebo in 
the mean (SE) changes in the number of SSEs (1.0 [0.1] vs 0.6 [0.1]), FSFI 
desire domain score (0.7 [0.1] vs 0.4 [0.1]), FSDS-R Item 13 score (-0.8 [0.1] 
vs -0.6 [0.1]), FSDS-R total score (-8.3 [0.6] vs -6.3 [0.6]), and FSFI total 
score (4.2 [0.4] vs 2.7 [0.4]; all P < 0.01). More women on flibanserin (37.6%) 
than women on placebo (28.0%) reported experiencing meaningful benefits from the 
study medication on treatment discontinuation. The most frequent adverse events 
associated with flibanserin were dizziness, somnolence, nausea, and headache.
CONCLUSIONS: In naturally postmenopausal women with HSDD, flibanserin, compared 
with placebo, has been associated with improvement in sexual desire, improvement 
in the number of SSEs, and reduced distress associated with low sexual desire, 
and is well tolerated.