March 3, 2009
Review Questions Effectiveness Of Sex Drive Patch
A top medical journal review claims that Procter & Gamble's Intrinsa testosterone patches appear to do little to boost a woman's sex drive after menopause, Reuters reported.
In 2004, U.S. regulators voted against approving the patches that deliver the male hormone, citing lack of evidence for their long-term safety.
"This testosterone patch has been studied in clinical trials involving over 1,000 surgically menopausal women with low sexual desire causing distress, treated for up to six months and was shown to be well tolerated," the company said in a statement.
It also said the company had put in place an independent safety advisory board and a robust risk management plan which is shared on a regular basis with the European Regulatory Authorities.
"In these clinical studies, the testosterone patch was shown to significantly increase satisfying sexual activity, increase sexual desire and reduce the related distress. These results were statistically significant versus women treated with placebo."
Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, said the published evidence so far is based on highly selected women and only shows small improvements in sexual parameters and large placebo responses.
"Also the long term safety of the treatment is unknown. Unwanted side effects are common and not always reversible. For all these reasons, we cannot recommend Intrinsa for use in women with sexual dysfunction," he added.
The researchers said the Intrinsa patch, which delivers a daily dose of testosterone, was recently licensed in Britain for women with hypoactive sexual desire disorder, characterized by persistently diminished or absent desire for sex, who have gone through menopause due to womb and ovary removal.
Studies in the past suggest that women suffering from diminished sex drive after menopause may have low levels of hormones such as testosterone. Men and women both produce testosterone, although men make more of it.
The study reviewed Intrinsa data that included nearly 4,000 women, yet most of the trials lasted less than six months, which made it difficult to determine long-term safety.
The review found that key trials for the patches also involved a select group of women in menopause due to surgery and neglected other mental or physical conditions that might have affected sex drive.
Iheanacho and colleagues said side effects were common and the improvements in patients sex drives were small, with many women not treated with the patch also reporting improvements.
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