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Effects of testosterone replacement in human immunodeficiency virus-infected women with weight loss.

Choi HH - J Clin Endocrinol Metab - 01-MAR-2005; 90(3): 1531-41
NLM Citation ID:
15613414 (PubMed)
Full Source Title:
Journal of Clinical Endocrinology and Metabolism
Publication Type:
Clinical Trial; Journal Article; Randomized Controlled Trial
Author Affiliation:
Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California 90059, USA.
Choi HH; Gray PB; Storer TW; Calof OM; Woodhouse L; Singh AB; Padero C; Mac RP; Sinha-Hikim I; Shen R; Dzekov J; Dzekov C; Kushnir MM; Rockwood AL; Meikle AW; Lee ML; Hays RD; Bhasin S
The objective of this study was to determine whether physiological testosterone replacement increases fat-free mass (FFM) and muscle strength and contributes to weight maintenance in HIV-infected women with relative androgen deficiency and weight loss. Fifty-two HIV-infected, medically stable women, 18-50 yr of age, with more than 5% weight loss over 6 months and testosterone levels below 33 ng/dl were randomized into this double-blind, placebo-controlled trial of 24-wk duration. Subjects in the testosterone group applied testosterone patches twice weekly to achieve a nominal delivery of 300 mug testosterone over 24 h. Data were evaluable for 44 women. Serum average total and peak testosterone levels increased significantly in the testosterone group, but did not change in the placebo group. However, there were no significant changes in FFM (testosterone, 0.7 +/- 0.4 kg; placebo, 0.3 +/- 0.4 kg), fat mass (testosterone, 0.3 +/- 0.7 kg; placebo, 0.6 +/- 0.7 kg), or body weight (testosterone, 1.0 +/- 0.9 kg; placebo, 0.9 +/- 0.8 kg) between the two treatment groups. There were no significant changes in leg press strength, leg power, or muscle fatigability in either group. Changes in quality of life, sexual function, cognitive function, and Karnofsky performance scores did not differ significantly between the two groups. High-density lipoprotein cholesterol levels decreased significantly in the testosterone group. The patches were well tolerated. We conclude that physiological testosterone replacement was safe and effective in raising testosterone levels into the mid to high normal range, but did not significantly increase FFM, body weight, or muscle performance in HIV-infected women with low testosterone levels and mild weight loss. Additional studies are needed to fully explore the role of androgens in the regulation of body composition in women.
Major Subjects:

Additional Subjects:

Chemical Compound Name:
(Androgens); 58-22-0(Testosterone)
Grant ID:
2RO1-DK-49296-02A DK NIDDK; 5P41-RR-000954 RR NCRR; G12-RR-03026 RR NCRR; ODP001397 OD NIH; P20-RR-11145 RR NCRR; U01-DK-54047 DK NIDDK; U54-HD-041748-01 HD NICHD

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