Guidelines needed for the use of androgens for women with sexual dysfunction

Dec 3 2004

The Endocrine Society, which represents more than 12,000 endocrinologists who are specially trained to diagnose, treat and conduct basic and clinical research on complex hormonal disorders, has called for new clinical guidelines on the use of androgens in women/female sexual dysfunction.

The organization also notes that additional research into androgens and women as well sexual dysfunction in women will help doctors and patients better understand how to diagnose and effectively treat this condition. This announcement comes as Intrinsa -- a testosterone skin patch for women -- is reviewed by the Food and Drug Administration as a treatment for a specific population of women who suffer from sexual dysfunction.

"Because of the growing recognition of female sexual dysfunction as well as the increase in women seeking treatment, The Endocrine Society is in the early stages of preparing clinical guidelines for the care of these patients," announced Endocrine Society President, Anthony Means, Ph.D. "As new treatments come available, we want to make sure that physicians understand how and when to use them to treat patients. We plan to release our clinical guidelines in 2005."

Female sexual dysfunction affects over 40 percent of women in the United States, according to a 1999 study from The Journal of the American Medical Association. As experts evaluate women with potential sexual interest disorders, there is a growing amount of information to guide them in how to understand, diagnose and treat these problems. Androgens -- hormones like testosterone that produce male characteristics -- are known to be involved in women's arousability, response and intensity and ease of orgasm, as well as in initial spontaneous desire. Androgens are also involved in the active neurovascular smooth muscle response of swelling and increased lubrication and likely affect genital sexual sensitivity. The testosterone patch that is being reviewed by the FDA this week would be designated specifically for women who have undergone a hysterectomy and are taking estrogen therapy. However, future research is needed to better understand how this therapy will impact other populations of women.

"The new testosterone treatment will potentially benefit a specific population of women with sexual dysfunction. However, it is not clear how effective this new therapy will be in the majority of women who suffer from this condition," comments Society President-Elect, Andrea Dunaif, M.D. "The process of female sexual arousal is quite complex. As a result, we need additional research to determine the best ways for doctors to treat female patients who suffer from sexual dysfunction."

If approved for use by the FDA, Intrinsa would be the first drug approved for women's sexual needs.

Several clinical trials have already examined the efficacy of androgen therapy in women. Preliminary results suggest that this treatment is effective in certain women, primarily when testosterone is administered at doses that raise free testosterone to the upper limits of normal. Free testosterone is that which circulates freely in the blood and is not bound to proteins.

According to Margaret Wierman, M.D., a Professor of Medicine at the University of Colorado Health Sciences Center, "Testosterone therapy increases libido, or sexual desire in some women. Mood and quality of life have also improved, as has bone mineral density."

Leading experts note that considerations related to androgen therapy in women include the type of treatment, risks and clinical monitoring of responses. While women have previously been prescribed testosterone in several forms including oral, buccal, transdermal and injectable, prior research on testosterone therapy in women has been done with pharmacological doses.

"Diagnosing androgen deficiency in women is problematic because it is difficult to accurately measure low testosterone levels and the normal, ranges for this hormone in women are not well established," notes Dr. Dunaif. "Research is needed to help us identify those women who truly have testosterone deficiency and would therefore benefit from hormonal therapy. In addition, the therapeutic window for testosterone in women is small and it is easy to cause symptoms of male hormone excess, such as hirsutism."

In a recent audio conference on androgens in women, which was sponsored by The Endocrine Society, leading experts outlined the steps that physicians should take to manage the treatment of women on androgen therapy. They include clinical monitoring, biochemical evaluation, radiographic assessments and possibly testosterone measurements. As part of clinical monitoring, skin should be checked for acne and hirsutism, which is excess face or body hair. Development of male characteristics, or virilization, though rare, should also be watched for. A breast examination before a woman starts therapy and twice a year thereafter is recommended. Other possible evaluations include hematocrit or hemoglobin determination, lipid measurement, yearly mammography and endometrial ultrasound. Some experts also suggest that free testosterone should be measured before treatment and monitored during treatment. Testosterone therapy has been studied previously in different groups of women, including women with adrenal insufficiency and premenopausal women with decreased libido, but not with low androgen levels.