Question the study addresses: Is flibanserin 100 mg qhs safe and effective for treating premenopausal women with acquired, generalized HSDD?
How the study was conducted: This analysis combined the data from BEGONIA, VIOLET, and DAISY studies of all the premenopausal women treated with flibanserin 100 mg qhs (n=2465). As with the individual studies, safety was assessed by adverse events, and efficacy was evaluated using the number of satisfying sexual events (SSEs), sexual desire (FSFI-desire domain), and associated distress after 6-months of treatment. In addition, as the sample size was more extensive, subgroup analyses were performed using baseline demographics and clinical characteristics.
Answer based on study findings: Treatment with flibanserin 100 mg qhs is safe and effective at increasing the number of SSEs, and sexual desire measured every 4 weeks and decreasing associated distress in certain premenopausal women with HSDD. In addition, improvements with flibanserin 100 mg were consistently more significant than placebo among most subgroups of women, with some exceptions. These exceptions included SSEs in women aged 18-34 years, associated distress in women with baseline FSFI-desire domain scores >1.8, and all efficacy endpoints in non-White or Hispanic premenopausal women.
