Dr. Goldstein describes LibiGel, a hormonal treatment to help women with sexual problems, and why women with menopause may be interested.
LibiGel is a topical form of testosterone that’s in a gel form that’s implied to the skin through a tube and would increase a woman’s testosterone. Nothing earth shattering about the concept. Prior to LibiGel there was an agent called Intrinsa, which was another topical form of testosterone delivered by a patch.
Intrinsa, the sort of beginning of FDA studies for testosterone in women, went through again many thousands of women who were given either placebo or the active drug and the data on efficacy was accepted by the agency, but the data on safety were not accepted.
There were several-year data and the agency wanted five or ten year data with hormones to see if there was a breast cancer or heart attack risk as was found in women who were in the Women’s Health Initiative who were taking this synthetic form of estrogen and synthetic form of progesterone.
So, Intrinsa was timed oddly because it was introduced to the FDA around the same time of all of the emotional response to the estrogen and breast cancer care. So LibiGel took the FDA head on. The company is BioSante; the actual individual design of study is Michael Snabes and he is just a remarkable individual who said, “Okay, if the FDA wants ten-year data we are going to do ten-year data”.
So actually here in San Diego we are part of a very large national clinical trial where we are taking women who have low interest and post-menopausal women and we are identifying if they get heart attacks and strokes while taking the medication.
The cool part of the LibiGel series currently is they now have three year’s data. They have more than a thousand post-menopausal women in the trial.
These data were presented to the Journal of Sexual Medicine and to meetings so I can share them with you, that in the three years they have a single breast cancer and they have a cardiovascular risk rate far less than the general population and the people that we need to study or that we are currently studying are women with diabetes and hypertension and smoking and older women where these events of heart attack and strokes and breast cancer would happen.
So, while the data are not blinded, excuse me, while the data are still blinded, they are not unblinded so we don’t know which person got the breast cancer, was it the active drug or the placebo, the fact is, the risk is so low that it’s sort of a moot point who has that.
So there is no signal of abnormal safety and this is a really cool concept so that one day we will now have flibanserin, a non-hormonal strategy to help women and theoretically, LibiGel, a hormonal strategy to help women and that would be major cool. We will be able to start to delve into the reasons for sexual problems in women with improved pharmacologic agents.
About Dr. Irwin Goldstein, M.D.:
Dr. Irwin Goldstein is Director of San Diego Sexual Medicine at Alvarado Hospital, the Secretary of the International Society for the Study of Women’s Sexual Health, a former President of the Sexual Medicine Society of North America and a Clinical Professor of Surgery at University of California at San Diego.
Dr. Goldstein has been involved with sexual dysfunction research since the late 1970s. His specialties include penile microvascular bypass surgery, surgery for dyspareunia, physiologic investigation of sexual function in men and women, and diagnosis and treatment of sexual dysfunction in men and women.