University Hospitals Case Medical Center's MacDonald Women's Hospital is leading an international trial investigating a first-of-its-kind on-demand drug for pre-menopausal women with sexual dysfunction. Led by Sheryl Kingsberg, PhD, this international Phase II study is one of the largest clinical studies to ever explore a "use-as-needed" treatment, Tefina, for women experiencing orgasmic disorder.
Tefina is a nasal gel containing testosterone and is inserted in the nose with an easy to use applicator 1-4 hours before sexual activity. The study, which will involve 240 patients 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.
"Tefina is a potentially revolutionary treatment to restore women's ability to obtain orgasm and sexual satisfaction" says Dr. Kingsberg, Primary Investigator of the study and Chief of Behavioral Medicine at UH MacDonald Women's Hospital. "Low sexual satisfaction is linked to a lower sense of well being as well as to tension in relationships. We are hopeful that this be a real help for patients who say 'sex has become a chore.'"
Anorgasmia, also known as female orgasmic disorder, is defined as the persistent or recurrent delay in or absence of orgasm. Although this condition affects 1 in 5 women worldwide, there are no approved treatments for anorgasmia.
Tefina, developed by Trimel Pharmaceutical Corporation, is a self-administered low-dose testosterone gel. The testosterone is absorbed through the nasal lining, resulting in a rise in levels throughout the body. Low testosterone is linked to low sexual desire and the development of climax problems. Testosterone therapy not only improves sexual desire through central actions in the brain but also results in increased vaginal blood flow, which is critical for sexual satisfaction.
"Female orgasmic disorder can be very frustrating for women who have previously enjoyed a satisfying sexual relationship," says Dr. Kingsberg, who is also Professor at Case Western Reserve University School of Medicine. "There is a vast need for new treatments for women with sexual difficulties as previous studies have shown that at least 5 percent of women are unable to achieve orgasm. Historically we have had little to offer women and progress has lagged way behind that of treatment for male sexual problems."