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Serotonin receptor shows promise in hypoactive sexual desire disorder
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Flibanserin, a serotonin receptor 1A agonist/serotonin receptor 2A antagonist, safely and effectively improved the sexual interactions of naturally postmenopausal women diagnosed with hypoactive sexual desire disorder, according to study results.
The SNOWDROP trial, conducted by James A. Simon, MD, of the Women’s Health and Research Consultants, George Washington University School of Medicine in Washington, D.C., was a multicenter, randomized, double blind, placebo-controlled trial that looked at 949 postmenopausal women with hypoactive sexual desire disorder (HSDD) and at least one ovary. These women were screened for a score of 15 or more on the Female Sexual Distress Scale – Revised (FSDS-R) and a score of 1 or zero on the Sexual Interest and Desire Inventory – Female, while not having any additional psychiatric complications such as suicide ideation or depression.
“These results demonstrate that flibanserin 100 mg [at bedtime] improves sexual desire, improves sexual function, and reduces distress related to loss of desire in naturally postmenopausal women with HSDD, and is well tolerated,” the researchers wrote. “This is the first time that a nonhormone pharmacological treatment has been shown to be effective for treating HSDD in postmenopausal women.”
James A. Simon
After 4 weeks of observation to determine baseline, the women were randomly assigned flibanserin (Sprout Pharmaceuticals) 100 mg once daily before bedtime (n=468) or placebo (n=481) for 24 weeks. Co-primary endpoints were changes from baseline to week 24 in the amount of satisfying sexual events (SSE) and in the Female Sexual Function Index (FSFI) desire domain score. Secondary endpoints were change from baseline in the FSDS-R item 13 score — this score assesses distress due to low sexual desire — as well as FSDS-R total score and FSFI total score.
The women maintained an electronic diary of their SSEs during a 28-day screening period.
There were improvements with flibanserin vs. placebo in the mean changes in the number of SSEs (1 vs. 0.6), FSFI desire domain score (0.7 vs. 0.4), FSDS-R item 13 score (–0.8 vs. –0.6), FSDS-R total score (–8.3 vs. –6.3), and FSFI total score (4.2 vs. 2.7; all P<0.01).
Meaningful benefits were reported by 37.6% of the women on flibanserin vs. 28% of women taking placebo. The most frequent adverse events reported with flibanserin were dizziness, somnolence, nausea and headache.
Disclosure: This study was funded by Boehringer Ingelheim, the previous owner of the flibanserin program. Simon and other researchers report financial relationships with a variety of companies, including Sprout. Please see study for full disclosure list.
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