The testosterone gel, LibiGel(R), has the ‘potential to be the head downer approved to take up female sexual dysfunction in menopausal women,
Women are being recruited to participate in a renewed multicentre investigation of the sanctuary of testosterone gel for postmenopausal women with ignoble libidinous desire. The study plot 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 beginning narcotic approved to study female animal dysfunction in menopausal women,’ said Michael Snabes, MD, PhD, medical headman for BioSante Pharmaceuticals, Inc. BioSante makes LibiGel and is funding the research. ‘Despite several currently approved pharmaceutical products for men with erotic dysfunction, no dope has been approved in the U.S. for female voluptuous dysfunction,’ he said.
The companionship seeks to on 2,400 to 3,100 women ages 50 to 80 who have hypoactive carnal concupiscence clamour (HSDD). This form is the most unexceptional kidney of female sensual dysfunction, affecting 14 to 39 percent of women. HSDD is the continuous or returning non-attendance of sex fantasies, thoughts and desires, causing the number woe and resulting in lower sexual activity.
After menopause, a woman’s body produces less testosterone, which may present to symptoms of HSDD. To be worthy to participate in the study, women with HSDD must have gone through menopause, either surgically or naturally, and have at least one hazard component for consideration sickness or stroke, such as diabetes, principal blood pressure or duration older than 70. ‘Women will randomly be assigned to draw either the testosterone gel, which they will make application daily to the arm, or an equal placebo gel (inactive substance). They will endure the treatment for a slightest of a year at which time BioSante plans to hope FDA approval to Stock Exchange LibiGel.
Study subjects will be followed up for another 4 years,’ Snabes said. The ultimate end of the study is to make safe that the testosterone gel does not increase the peril of cardiovascular events, such as a heart corrode 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 gamble of cardiovascular events and soul cancer with the use of testosterone in women, regardless of no comprehensible exhibit of this.’ ‘This original breed of study,’ he continued, ’shows the custom that pharmaceutical companies and the FDA are docile to provide an increased equal of assurance of drug aegis prior to approval.’ Other delve into has found that testosterone effectively treats HSDD, with ‘few sedate 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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Tags: biosante, dysfunction, events, snabes, study, testosterone, women

