Libido Gel For Women .com
What Is LibiGel?
LibiGel is a low-dose testosterone gel designed for women who suffer Female Sexual Dysfunction (FSD) specifically Hypoactive Sexual Desire Disorder in Menopausal Women (HSDD), applied to the upper arm once a day, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner to reduce skin reactions compared to other forms of transdermal delivery systems like patches.
Currently there is no FDA approved pharmaceutical product to treat FSD in the U.S. and if approved, LibiGel may help address the unmet medical need.
BioSante’s lead product LibiGel, has two Phase III clinical trials in progress covered by an SPA (Special Protocol Assessment) with the FDA, to demonstrate the safety and efficacy of LibiGel, in the treatment of HSDD.
BioSante’s lead product LibiGel, has concluded the enrollment of its final Phase III cardiovascular and breast cancer safety study, with cardiovascular events lower than expected. An amount of 3,656 women were enrolled with over 4,800 women-years exposure of LibiGel with only 29 adjudicated cardiovascular events reported, a lower event rate of approximately 0.60% and 17 breast cancers reported, a rate of approximately 0.35%, which is in line with the ages of the subjects participating in the study.
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