Speciality pharmaceutical company BioSante Pharmaceuticals has completed the pharmacokinetic study of LibiGel, a transdermal testosterone gel for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder.
The double-blind and placebo-controlled Phase II trial, which included 24 postmenopausal subjects, showed that testosterone blood levels were similar on days 14, 21, 42 and 63, indicating that there was no increase in testosterone blood levels with daily LibiGel treatment.
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It also found that free and bioavailable testosterone returned to baseline levels within 36-48 hours after the last dose of LibiGel, indicating effective elimination after dosing is stopped.
The trial demonstrated that the gel increased the number of satisfying sexual events in surgically menopausal women suffering from hypoactive sexual desire disorder by 238% compared to the baseline.
Two double-blind, placebo-controlled Phase III efficacy trials involving more than 500 surgically menopausal women each are ongoing.
In addition, BioSante is conducting a Phase III cardiovascular events and breast cancer LibiGel safety study, as part of an new drug application submission.
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By GlobalDataBioSante plans to submit the application to the US Food and Drug Administration in the fourth quarter of 2012.
