The testosterone gel, LibiGel(R), has the ‘potential to be the inception medicate approved to deal with female sexual dysfunction in menopausal women,
Women are being recruited to participate in a fresh multicentre den of the aegis of testosterone gel for postmenopausal women with inferior erotic desire. The study shape and goals will be presented at The Endocrine Society’s 90th Annual Meeting in San Francisco. The testosterone gel, LibiGel(R), has the ‘potential to be the firstly treat approved to explore female sensuous dysfunction in menopausal women,’ said Michael Snabes, MD, PhD, medical chief for BioSante Pharmaceuticals, Inc. BioSante makes LibiGel and is funding the research. ‘Despite several currently approved pharmaceutical products for men with fleshly dysfunction, no medication has been approved in the U.S. for female bodily dysfunction,’ he said.
The party seeks to recruit 2,400 to 3,100 women ages 50 to 80 who have hypoactive procreant desideratum disorderliness (HSDD). This brainwash is the most general font of female propagative dysfunction, affecting 14 to 39 percent of women. HSDD is the unwavering or habitual non-existence of earthy fantasies, thoughts and desires, causing the chick sadness and resulting in lower sexual activity. After menopause, a woman’s body produces less testosterone, which may present to symptoms of HSDD.
To be proper to participate in the study, women with HSDD must have gone through menopause, either surgically or naturally, and have at least one chance particular for verve malady or stroke, such as diabetes, apex blood pressure or stage older than 70. ‘Women will randomly be assigned to gain either the testosterone gel, which they will use daily to the arm, or an like placebo gel (inactive substance). They will ascertain the treatment for a nadir of a year at which time BioSante plans to endeavour FDA approval to bazaar LibiGel. Study subjects will be followed up for another 4 years,’ Snabes said.
The unadulterated sighting of the study is to insure that the testosterone gel does not increase the imperil of cardiovascular events, such as a heart decompose or stroke, or the risk of breast cancer. ‘The FDA [Food and Drug Administration] has requested this preapproval study,’ Snabes said, ‘due to a perceived jeopardize of cardiovascular events and core cancer with the use of testosterone in women, notwithstanding no pellucid exhibit of this.’ ‘This callow category of study,’ he continued, ’shows the available that pharmaceutical companies and the FDA are acquiescent to provide an increased smooth of assurance of drug safe keeping prior to approval.’ Other exploration has found that testosterone effectively treats HSDD, with ‘few acute adverse events associated with its use,’ Snabes said.
However, there are no long-term studies of testosterone use in women. The Endocrine Society has called for more long-term data.
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