Important note: Information in this article was accurate in September 2000. The state of the art may have changed since the publication date.AIDSWEEKLY Plus; Monday, September 18, 2000
Prepared by AIDS Weekly editors from staff and other reports
NewsRx -- Transdermal testosterone (T) replacement therapy effectively raises serum total and free T levels in androgen-deficient HIV infected women, researchers have found.
"Androgen deficiency in HIV infected women is associated with loss of muscle mass and function," stated Marjan Javanbakht and colleagues from Charles Drew University, California, and Watson-TheraTech, Inc., Utah. "Transdermal T replacement has been proposed for the treatment of HIV associated weight loss. We, therefore, investigated the pharmacokinetics of a testosterone matrix transdermal system (TMTDS) in eight menstruating HIV infected women, 18-50 years, who had been on stable antiretroviral therapy including a protease inhibitor for >12 weeks, and nine healthy, menstruating women."
Javanbakht et al. presented data from their study at the ENDO 2000 conference, Shaping the Future of Endocrinology: Today's Research ... Tomorrow's Care, held in Toronto, Ontario, Canada. The title of their presentation was "Pharmacokinetics of a novel testosterone matrix transdermal system in healthy, premenopausal women and women infected with human immunodeficiency virus."1.
Women provided a baseline blood sample during their early follicular phase after which two TMTDS patches were applied to their skin. The researchers expected the patches to deliver T at a rate of 300 ug/day over an application period of three to four days. After wearing the first set of patches for 72 hours, they were removed and a second set of two patches were applied. Blood samples were drawn over 96 hours.
The researchers found that the baseline serum total and free T levels were lower in HIV infected women as compared to the healthy women. They noted that there was a diurnal rhythm of T secretion. Higher levels were observed in the morning, and lower levels were found in the late afternoon in both groups of women.
The healthy women had free T levels that rose slightly above normal during the T therapy. In the HIV infected women, free T levels were in the low-normal range before therapy and rose into the upper-normal range during the T therapy, reported Javanbakht et al.
"The mean increments in free and total T levels in HIV infected women (free +3.0 pg/mL; total +15.7 ng/dL) were significantly lower than in healthy women (free +5.2 pg/mL; total +34.6 ng/dL), both p<0.05," reported Javanbakht et al. "Assuming a daily T delivery oral of 300 ug/day, the apparent plasma T clearance was significantly higher in HIV infected (2531 L/day) than healthy women (1127 L/day), p=0.022."
The researchers observed no significant change from baseline in serum luteinizing hormone, SHBG, and estradiol levels in either group although serum follicular stimulating hormone levels showed a greater decrease from baseline in the healthy women during therapy. Both groups of women tolerated the patches well.
"A regimen of two TMTDS patches applied twice weekly maintains serum total and free T levels in mid- to upper-normal range in androgen-deficient HIV infected women," concluded Javanbakht et al. "The lower increments of serum total and free T levels in HIV infected women, as compared to healthy women, appear to reflect increased plasma clearance."
The corresponding author for this study is Marjan Javanbakht, Charles Drew University, Los Angeles, California, USA.
A search of the www.NewsRx.com online database using the terms "testosterone" and "replacement" yielded 48 articles.
Key points reported in this study are:
This article was prepared by AIDS Weekly editors from staff and other reports.
Reference:
1. Javanbakht M, Singh AB, et al., "Pharmacokinetics of a novel testosterone matrix transdermal system in healthy, premenopausal women and women infected with the human immunodeficiency virus", J Clin Endocrinol Metab 2000 Jul;85(7):2395-4
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