Clinical trial to treat Female Orgasmic Disorder

Columbia University School of Nursing is the only site in New York State, and one of only 30 international sites selected to participate in a clinical trial to treat Acquired Female Orgasmic Disorder. The study will test whether a nasal gel containing bio-identical testosterone when applied to the mucous membranes of the nose will restore a woman's ability to obtain orgasm and sexual satisfaction.

The clinical trial, which will involve 240 participants in the U.S., Canada and Australia, will evaluate if there is an increase in the occurrence of orgasm over the treatment period compared against baseline levels in women experiencing the orgasmic disorder also known as Female Anorgasmia (www.clinicaltrials.gov). The disorder is estimated to affect as many as 1 in 5 women worldwide.

In the US, there are no FDA-approved treatments. In other countries, current treatment for the disorder relies on testosterone treatments using an oral or skin patch delivery system which must be continuously delivered at relatively higher doses to be effective. The gel is designed to adhere to the nasal wall allowing testosterone to be slowly absorbed through the nasal lining within 10-15 minutes of application, thus reducing unnecessary exposure.

"Unfortunately, the causes of female orgasmic disorder are still unknown and conventional methods to address the issue raise the risk of increased side effects and have had only a modest improvement in physical sexual satisfaction," says Nancy Reame, PhD, Professor of Disease Prevention and Health Promotion and the principal investigator for the study. "This clinical trial will help determine whether this novel approach is a safe and effective treatment for a serious sexual disorder that can impact a women's enjoyment of sexual activity and can have lasting effects on her personal relationships."