Body weight increased in all groups, including the group receiving placebo, during the double-blind phase ( +/- , +/- , +/- , and +/- kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively; all P < vs. baseline). BCM increased from baseline in all groups ( +/- , +/- , +/- , and +/- kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively). At 12 weeks, only the gain in weight at the 40-mg dose of oxandrolone and the gain in BCM at the 40- and 80-mg doses of oxandrolone were greater than those in the placebo group, however. Oxandrolone treatment was associated with significant suppression of sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, and total and free testosterone levels. Treatment was generally well tolerated but accompanied by significant increases in transaminases and low-density lipoprotein as well as decreases in high-density lipoprotein.