The testosterone gel, LibiGel(R), has the ‘potential to be the pre-eminent antidepressant approved to touch on female sexual dysfunction in menopausal women,
Women are being recruited to participate in a callow multicentre think over of the safe keeping of testosterone gel for postmenopausal women with tearful procreant desire. The study mould 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 blue ribbon stimulant approved to take out female reproductive dysfunction in menopausal women,’ said Michael Snabes, MD, PhD, medical guide for BioSante Pharmaceuticals, Inc. BioSante makes LibiGel and is funding the research. ‘Despite several currently approved pharmaceutical products for men with carnal dysfunction, no tranquillizer has been approved in the U.S. for female sex dysfunction,’ he said.
The comrades seeks to put down 2,400 to 3,100 women ages 50 to 80 who have hypoactive bodily lustfulness ailment (HSDD). This accustom is the most collective typeface of female earthy dysfunction, affecting 14 to 39 percent of women. HSDD is the persevering or regular non-presence of lustful fantasies, thoughts and desires, causing the bride plague and resulting in lower sexual activity.
After menopause, a woman’s body produces less testosterone, which may give to symptoms of HSDD. To be appropriate to participate in the study, women with HSDD must have gone through menopause, either surgically or naturally, and have at least one gamble agent for sympathy bug or stroke, such as diabetes, extraordinary blood pressure or majority older than 70. ‘Women will randomly be assigned to away with either the testosterone gel, which they will go after daily to the arm, or an duplicate placebo gel (inactive substance). They will come by the treatment for a minimal of a year at which time BioSante plans to demand FDA approval to trade LibiGel. Study subjects will be followed up for another 4 years,’ Snabes said.
The embryonic intention of the study is to certain that the testosterone gel does not increase the danger of cardiovascular events, such as a heart criticize 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 jeopardy of cardiovascular events and soul cancer with the use of testosterone in women, notwithstanding no starkly attest of this.’ ‘This renewed group of study,’ he continued, ’shows the disreputable that pharmaceutical companies and the FDA are avid to provide an increased consistent of assurance of drug refuge prior to approval.’ Other investigating has found that testosterone effectively treats HSDD, with ‘few humourless 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.
Honoured link: read there
Tags: snabes, study, testosterone, women