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Study Suggests Replacing Testosterone for Women With HIV: Presented at CROI

By Roberta Friedman, PhD

SAN FRANCISCO, CA -- February 12, 2004 -- Women with low testosterone and weight loss may benefit from boosting the hormone back into the normal range, according to results of a double-blinded trial presented here February 11^th at the 11^th Annual Conference on Retroviruses and Opportunistic Infections.

The study used a transdermal patch that delivers a physiologic dose of 4 mg/day of testosterone in a cohort of women. Investigator Sara Dolan, RN, nurse practitioner, Massachusetts General Hospital, Boston, said, "Our goal was to bring people back from below normal [testosterone levels], into a physiological range." Women typically have 10% of the levels present in men, Ms. Dolan said.

Women infected with HIV can lose libido, energy, and body weight, as well as muscle mass, Dolan said. The study recruited women with testosterone below 3.0 pg/mL, and weight below 90% of ideal, or more than a 5% loss compared to before illness.

The 6-month trial randomized 57 women to active or placebo patch placed on alternating sites on the abdomen, twice weekly. Active patches delivered an estimated 150 mcg/day. Prior studies of testosterone in women had used pharmacologic dosing, Dolan said.

Women in the trial (66% Caucasian) averaged a body mass index (BMI) of 20.8, and an average weight loss of 18.7%. Average viral load was 1419 copies/mL, and 91% were on antiretroviral drugs.

Those subjects on the placebo patch continued to demonstrate low levels of testosterone -- with 87% below the median range. Active patch, however, produced testosterone above the median in 88% of the patients.

All of the subjects had lowered z scores on a test of muscle function, but the active patch increased muscle function significantly (P < .05). Placebo patch produced a further decline in muscle function, Ms. Dolan said.

Well-being scales also showed an improvement with active patch. No adverse effects were evident, including liver function, menstruation, and metabolic indices. No instances of hirsutism resulted from this treatment.


[Study title: Effects of Testosterone Administration in HIV-infected Women with Low Weight: A Randomized, Placebo-controlled Study. Abstract 151]

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