Register for Phase II clinical trial initiated for testosterone gel
BioSante Pharmaceuticals, Inc.November 13, 2002
2002 NOV 13 - (NewsRx.com & NewsRx.net) -- BioSante Pharmaceuticals, Inc., (BISP) announced that it has initiated a phase II clinical trial of LibiGel (testosterone gel) for the treatment of female sexual dysfunction (FSD).
The trial, being conducted in the United States and Canada, is a double-blind, placebo-controlled study that will enroll approximately 120 patients to determine the effect of LibiGel on women's sexual desire and activity.
BioSante has completed three phase I/II LibiGel clinical trials to determine blood levels of testosterone delivered by six different doses of LibiGel, which is administered as a topical gel. Data from these studies were presented by Dr. James A. Simon, clinical professor of obstetrics and gynecology at the George Washington University School if Medicine in Washington, DC, during a recent meeting of The North American Menopause Society.
"The data presented at The North American Menopause Society Meeting...indicate that LibiGel delivers the blood levels of testosterone believed to be necessary to improve women's libido," said Stephen M. Simes, BioSante.
LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application on the arms, shoulders, or abdomen, delivering testosterone to the blood stream evenly over time and in a noninvasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. Studies have shown that testosterone replacement therapy can increase bone density, raise energy levels, improve mood, and boost sexual desire and pleasure.
The company cites survey results published in the Journal of the American Medical Association that reported 43% of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32% lacked interest in sex and 26% could not experience orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical. This article was prepared by Biotech Week editors from staff and other reports.
©Copyright 2002, Biotech Week via NewsRx.com & NewsRx.net
