MONDAY, Oct. 3 (HealthDay News) -- Flibanserin is a safe and effective treatment for premenopausal women with hypoactive sexual desire disorder (HSDD), according to a study published online Sept. 20 in The Journal of Sexual Medicine.
Evan R. Goldfischer, M.D., from Hudson Valley Urology in Poughkeepsie, N.Y., and colleagues investigated continued efficacy and safety of flibanserin in premenopausal women with HSDD. A cohort of 738 women received open-label flibanserin (50 mg or 100 mg/day) for 24 weeks. Subsequently, those with a predefined response (an increase of ≥2 satisfying sexual events [SSE] and/or ≥4 desire days from baseline to weeks 21 to 24) were randomly allocated to receive either 24 weeks of flibanserin or placebo. A change in the number of SSE and desire score were coprimary end points. Secondary end points included Female Sexual Function Index (FSFI) total and desire domain scores, and Female Sexual Distress Scale-Revised (FSDS-R) total and Item 13 scores were assessed.
The investigators found that mean SSE and desire score approximately doubled, and FSFI, FSDS-R total, and Item 13 scores improved during the open-label period. From the start of the placebo trial to the end of the study, SSE, desire score, FSFI desire domain and total scores, and FSDS-R total and Item 13 scores improved significantly more with flibanserin treatment than placebo. Flibanserin was well-tolerated and caused no withdrawal reactions.
"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," the authors write.
Several authors disclosed financial ties with the pharmaceutical industry, including Boehringer Ingelheim, which funded the trial.
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