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An Update on Testosterone Therapy

by Dr. Barb DePree

Recently, Dr. Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Case Medical Center, professor in Reproductive Biology and Psychiatry at Case Western Reserve University, and a MiddlesexMD advisor, was interviewed by Dr. Michael Krychman, another MiddlesexMD advisor, for an online feature about the state of testosterone therapy for women.

Since we were able to be a fly on the wall, here’s the takeaway:

Despite a few advances in the research, the general state of affairs surrounding testosterone therapy for women remains fairly untested and inconsistent.

Unlike in Europe, which has approved Proctor & Gamble’s testosterone patch for women, the US Food and Drug Administration has no approved testosterone therapies. Women who receive testosterone therapy in the US get it “off-label,” meaning that either products designed for men are prescribed in small doses for women, or it’s compounded by a pharmacist without regulation or oversight. And that’s the way it’s been done in the US for decades.

In the meantime, research on testosterone products for women proceeds in fits and starts, and there simply hasn’t been a lot of it. Two large efficacy trials of BioSante Pharmaceuticals’ new LibiGel testosterone product found no significant difference between it and a placebo. The company is continuing with five-year safety trials, however, to determine if long-term use causes adverse health effects in women—specifically, cardiovascular disease or breast cancer.

“They’re moving forward with the [safety] trial, so that is hugely exciting,” says Sheryl.

The goal of testosterone treatment is to return a woman’s testosterone to pre-menopausal levels; treatment protocols for clinicians are fairly undefined, although the North American Menopause Society has recently updated its practice guidelines. Most blood tests aren’t sensitive enough to pick up such low levels of testosterone, and there’s no correlation between blood testosterone levels and libido. That means that while blood tests to establish baseline levels can be helpful, a clinician has to rely on observation and the patient’s reported experience.

And determining whether a woman is a good candidate for testosterone therapy also remains something of an art as well as a science.

“Testosterone is an important option for women—but it’s not for every woman,” says Sheryl. “We know that testosterone therapy won’t necessarily be effective in all women, so it’s important not only to measure efficacy and safety, but also to think about other treatment options.

“The first thing a clinician needs to assess is which women would really make use of testosterone replacement, and which women have something else going on,” she adds.

Good candidates are women who have lost their biological drive for sex, which is the classic definition of hypoactive sexual desire disorder: They have no desire, no fantasies, no dreams, no “hunger for sex,” as opposed to women who may have lost interest in sex, but who may have relationship issues or other stressors in their lives.

Because of the dearth of research and treatment protocols, clinicians should monitor their patients who are on testosterone therapy to make sure that it’s both effective and at safe levels, although, as Sheryl points out, the amount of testosterone in most treatments is very low.

And despite the frustrating lack of options and research surrounding testosterone therapy, women who are troubled by low libido shouldn’t be embarrassed about asking for help. “Hypoactive sexual desire disorder is the most common sexual problem across all ages,” says Sheryl. “About 10 percent of women have it, and they deserve to be assessed and treated because sex is important to overall health and quality of life.”


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