Women are being recruited to participate in a new study into the safety of testosterone gel for postmenopausal women with low sexual desire. Although there are several currently approved pharmaceutical products for men with sexual dysfunction, no drug has been approved in the U.S. for female sexual dysfunction. The company seeks to enroll up to 3,100 women aged between 50 and 80 who have hypoactive sexual desire disorder (HSDD). This condition is the most common type of female sexual dysfunction, affecting 14 - 39 percent of women. HSDD is the persistent or recurrent absence of sexual fantasies, thoughts and desires, causing the woman distress and resulting in lower sexual activity. Scientists speculate that after menopause, a woman's body produces less testosterone, which may contribute to symptoms of HSDD.
The study will use the testosterone gel LibiGel®, which the developers say has the potential to be the first drug approved to treat female sexual dysfunction in menopausal women. To be eligible to participate in the study, women with HSDD must have gone through menopause, either surgically or naturally, and have at least one risk factor for heart disease or stroke, such as diabetes, high blood pressure or age older than 70.
"Women will randomly be assigned to receive either the testosterone gel, which they will apply daily to the arm, or an identical placebo gel (inactive substance). They will receive the treatment for a minimum of a year at which time BioSante plans to seek FDA approval to market LibiGel. Study subjects will be followed up for another 4 years," said the developers. The primary aim of the study is to ensure that the testosterone gel does not increase the risk of cardiovascular events, such as a heart attack or stroke, or the risk of breast cancer.
Related:
More info on participating in the study
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Source: The Endocrine Society
