A paper published in the July edition of The Journal of Sexual Medicine has indicated that taking testosterone does not make menopausal women more likely to develop breast cancer.
The study has been greeted with approval by Biosante Pharmaceuticals Inc, which is developing a topical testosterone gel to treat hypoactive sexual desire disorder in women. The gel, named Libigel, is currently in Phase III clinical trials to assess its safety.
The study was done at the Department of Medicine at Alfred Hospital in Australia and was lead by Susan Davies, of the Women’s Health Program. The researchers evaluated 631 women who were treated with testosterone between 1989 and January 2007 as part of a clinical endocrinology practice.
They discovered that testosterone therapy was not associated with any statistically significant increase in the likelihood of a women developing breast cancer compared to the control population and furthermore concluded that testosterone exposure did not increase the risk of breast cancer.
The women took the testosterone on average for 1.3 years and were followed for a further 6.7 years. Taking into account the total number of years the women were followed for, the incidence rate of invasive breast cancer was 299 per 100,000 person-years, very similar to the rate reported for hormone therapy non-users.
BioSante recently issued a press release saying that they considered the study “another significant and reassuring set of data” showing that testosterone therapy was a safe way to treat hypoactive sexual desire disorder.
Libigel is the only treatment currently in development for the treatment of HSDD in menopausal women and Biosante are hopeful that it will be the first product the FDA approves for the treatment of the condition. They said that they are planning to seek new drug approval from the FDA in mid-2011.