T09-O-15 The rose study: placebo-controlled randomized withdrawal trial of flibanserin for hypoactive sexual desire disorder in premenopausal women - 27/06/08
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Résumé |
Introduction |
Hypoactive Sexual Desire Disorder (HSDD) is a common problem. This is the first randomized treatment withdrawal trial in premenopausal women with HSDD. It is assessing the efficacy and safety of a centrally acting non-hormonal agent, flibanserin.
Methods |
Premenopausal women with generalized, acquired HSDD for >6 months were entered if they were in a stable, monogamous, heterosexual relationship for >1 year, successfully completed the e-Diary For HSDD Trials© daily during 4 weeks of screening, and had no interfering medical problems. After a 24 week open-label flexible dosing phase, those subjects meeting enrichment criteria, were randomized to double-blind, placebo-controlled treatment for another 24 weeks. Co-primary endpoints were change in desire score and monthly satisfying sexual events.
Results |
Of 1156 women screened, 738 were treated; 67.1% completed the open-label period.
Conclusion |
Randomization has been completed for the Rose study, a placebo-controlled randomized withdrawal trial of a centrally acting non-hormonal agent, flibanserin, for generalized, acquired HSDD in premenopausal women.
Financial Support |
The study was funded by Boehringer Ingelheim.
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Vol 17 - N° S1
P. 121 - janvier-mars 2008 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.