About LibiGel and Female Sexual Dysfunction (FSD)

LibiGel is a once-daily transdermal testosterone gel in late-stage clinical development for the treatment of FSD in surgically menopausal women who have had both ovaries removed. LibiGel's formulation of bioidentical testosterone is quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly over time in a non-invasive, painless manner.
Approximately 43 percent of American women suffer from FSD, according to a study published in the Journal of the American Medical Association. FSD is often defined as a lack of sexual desire, arousal or pleasure. The majority of women with FSD are postmenopausal, experiencing symptoms due to hormonal changes that occur with aging, or with natural or surgical menopause.

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WE DONT CONDONE THE USE OF ILLEGAL STEROIDS HERE WE JUST ADVISE PEOPLE HOW TO USE THEM SAFELY AND EFFECTIVELY....FOR ENTERTAINMENT PURPOSES.....

phase III trial for Libigel, female viagra

"Based on discussions with the FDA and our positive results from the LibiGel Phase II study, we are moving forward into Phase III pivotal studies of women with low sexual desire, the largest component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD
)," said Stephen M. Simes, president and chief executive officer of BioSante.

"We are encouraged by the clinically significant improvement in sexual events with LibiGel treatment in the Phase II study," said Michael C. Snabes, MD, PhD, a reproductive endocrinologist and Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology and BioSante's key clinical development consultant. "Since there are no medications approved by the FDA for the treatment of this common disorder, there is significant demand by patients and their physicians. We are hopeful that if and when LibiGel is approved by the FDA that LibiGel treatment will be able to improve the sex lives of women with low sexual desire and activity."

"We are pleased to be moving into Phase III clinical development of LibiGel. Female sexual dysfunction is underserved by the pharmaceutical industry today. LibiGel may help address this unmet medical need. We believe two Phase III safety and efficacy trials plus one year of safety data are the essential requirements for submission and approval by the FDA of a new drug application (NDA)," said Stephen M. Simes. "With the initiation of this Phase III LibiGel trial and our recent FDA approval of Elestrin[TM] (estradiol gel), this is a very exciting time for BioSante," he added.

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WE DONT CONDONE THE USE OF ILLEGAL STEROIDS HERE WE JUST ADVISE PEOPLE HOW TO USE THEM SAFELY AND EFFECTIVELY....FOR ENTERTAINMENT PURPOSES.....

The drug--a form of testosterone called LibiGel that's rubbed into the upper arm--is at least two years away from pharmacy shelves. But Lincolnshire-based BioSante Pharmaceuticals helped sponsor a meeting of sex experts last week, seeking to convince them the company's on the right track.

Some are betting that a pill similar to an antidepressant could get there first. Boehringer Ingelheim Pharmaceuticals presented data at the same meeting showing that its drug, flibanserin, was significantly better than a sugar pill at improving the sex lives of women distressed over a loss of libido.

Lack of desire is typically women's most common sexual complaint, and drug companies have been racing to offer a medical solution. The issue was a central topic at the meeting of the International Society for the Study of Women's Sexual Health, which ended Sunday.

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WE DONT CONDONE THE USE OF ILLEGAL STEROIDS HERE WE JUST ADVISE PEOPLE HOW TO USE THEM SAFELY AND EFFECTIVELY....FOR ENTERTAINMENT PURPOSES.....