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Co. has conducted a Phase 1 study in 32 pre-menopausal women without sexual dysfunction, in which the drug was shown to be safe and well tolerated. A secondary endpoint in this study was the assessment of drug s effect on vaginal blood flow. Results showed a significant difference in the increase in vaginal blood flow in subjects treated with drug versus placebo. A Phase 2A pilot clinical study evaluating drug in 18 pre-menopausal women diagnosed with FSD has also been completed with favorable results. Key Clinical Findings from Phase 2A Study: patients receiving drug reported increases in their levels of sexual desire and genital arousal compared to placebo correlation found between sexual desire and genital arousal in patients receiving drug side effects were mild, including: nausea headache nasal congestion A Phase 2 at-home study of drug in FSD patients is planned for late 2005. |
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