Teenage fantasies

Women are being recruited to participate in a budding multicentre investigation of the cover of testosterone gel for postmenopausal women with ineffective sensual desire. The study lay out 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 in the first place medicament approved to manage female reproductive dysfunction in menopausal women,’ said Michael Snabes, MD, PhD, medical administrator for BioSante Pharmaceuticals, Inc. BioSante makes LibiGel and is funding the research. ‘Despite several currently approved pharmaceutical products for men with erotic dysfunction, no poison has been approved in the U.S. for female animal dysfunction,’ he said.

The establishment seeks to join 2,400 to 3,100 women ages 50 to 80 who have hypoactive propagative hunger battle royal (HSDD). This circumstance is the most workaday category of female procreant dysfunction, affecting 14 to 39 percent of women. HSDD is the persevering or regular non-attendance of sex fantasies, thoughts and desires, causing the miss agony and resulting in lower sexual activity. After menopause, a woman’s body produces less testosterone, which may donate to symptoms of HSDD.

To be fit to participate in the study, women with HSDD must have gone through menopause, either surgically or naturally, and have at least one imperil determinant for quintessence virus or stroke, such as diabetes, turbulent blood pressure or adulthood older than 70. ‘Women will randomly be assigned to gather either the testosterone gel, which they will interview daily to the arm, or an selfsame placebo gel (inactive substance). They will get the treatment for a minimal of a year at which time BioSante plans to aspire FDA approval to trade LibiGel.

Study subjects will be followed up for another 4 years,’ Snabes said. The leading objective of the study is to confirm that the testosterone gel does not increase the hazard of cardiovascular events, such as a heart denounce 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 chance of cardiovascular events and tit cancer with the use of testosterone in women, in defiance of no guileless averment of this.’ ‘This restored class of study,’ he continued, ’shows the unconcealed that pharmaceutical companies and the FDA are pleased to provide an increased plain of assurance of drug sanctuary prior to approval.’ Other scrutinization has found that testosterone effectively treats HSDD, with ‘few sober 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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