DBPC Pase 3 study using 150mgs of oxandrolone per day

cvictorg

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http://retroconference.org/2004/cd/PDFs/725.pdf

Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV-wasting

Study Design: Double-blind, randomized, placebo-controlled trial of 89 HIV-positive women and men with wasting assigned to the anabolic steroid oxymetholone (50 mg BID or TID) or placebo for 16 weeks followed by open-label treatment.Results: Oxymetholone led to a significant weight gain of 3.0 ±0.5 and 3.5 ±0.7 kg in the TID and BID groups, respectively (p<0.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0 ±0.7 kg. Body cell mass increased in the oxymetholone BID group (3.8 ±0.4 kg; p<0.0001) and in the oxymetholone TID group (2.1 ±0.6 kg; p<0.005), corresponding to 12.4% and 7.4% of baseline BCM, respectively. The most important adverse event was liver-associated toxicity. Overall, 35% of patients in the TID, 27% of patients in the BID oxymetholone group and no patients the placebo group had a greater than 5 times baseline increase for ALT during the double-blind phase of the study.

Conclusions: Oxymetholone can be considered an effective anabolic steroidin eugonadal male and female patients with AIDS-associated wasting. The BID (100 mg/day) regimen appeared to be equally effective to the TID (150 mg/day) regimenin terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity.

DISCUSSION

Oxymetholone equaled or surpassed the gains in weight and LBM observed with cytokine inhibitors, nutritional supplements and rGH, its side effect profile was different. The suppression of pituitary gonadotropins, that regulate the endogenous testosterone, occurs by a negative feed back loopand represents a well-known side effect of anabolic steroids. When other first-line therapies such as optimizing nutritional status and gonadal function or the use of exercise have failed, oxymetholone can be considered an effective anabolic steroidin male and female patients with AIDS wasting, promoting significant gains in LBM and BCM. Reference:
 
http://retroconference.org/2004/cd/PDFs/725.pdf

Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV-wasting

Study Design: Double-blind, randomized, placebo-controlled trial of 89 HIV-positive women and men with wasting assigned to the anabolic steroid oxymetholone (50 mg BID or TID) or placebo for 16 weeks followed by open-label treatment.Results: Oxymetholone led to a significant weight gain of 3.0 ±0.5 and 3.5 ±0.7 kg in the TID and BID groups, respectively (p<0.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0 ±0.7 kg. Body cell mass increased in the oxymetholone BID group (3.8 ±0.4 kg; p<0.0001) and in the oxymetholone TID group (2.1 ±0.6 kg; p<0.005), corresponding to 12.4% and 7.4% of baseline BCM, respectively. The most important adverse event was liver-associated toxicity. Overall, 35% of patients in the TID, 27% of patients in the BID oxymetholone group and no patients the placebo group had a greater than 5 times baseline increase for ALT during the double-blind phase of the study.

Conclusions: Oxymetholone can be considered an effective anabolic steroidin eugonadal male and female patients with AIDS-associated wasting. The BID (100 mg/day) regimen appeared to be equally effective to the TID (150 mg/day) regimenin terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity.


I believe your thread title is mislabeled!!! The study by Hengge et al used Oxymtholone (Anadrol-50). The title of Oxandrolone at 150 mg immediately grabbed my attention. I am very familiar with this study (and all of Hengge's work). Would you like me to comment?
 

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I believe your thread title is mislabeled!!! The study by Hengge et al used Oxymtholone (Anadrol-50). The title of Oxandrolone at 150 mg immediately grabbed my attention. I am very familiar with this study (and all of Hengge's work). Would you like me to comment?

You are correct - I apologize - please comment
 
You are correct - I apologize - please comment

A number of Hengge et al. publications do contain results for the sex hormones during oxymetholone administration. These studies establish the HPTA suppressive effects of oxymetholone administration. In 2003, Hengge et al. results from two published studies are from the same population. [Hengge UR, Stocks K, Faulkner S, et al. Oxymetholone for the treatment of HIV-wasting: a double-blind, randomized, placebo-controlled phase III trial in eugonadal men and women. HIV Clin Trials 2003;4:150-63. Hengge UR, Stocks K, Wiehler H, et al. Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting. Aids 2003;17:699-710.]

The study is a randomized, placebo controlled phase III study of oxymetholone. Patients were randomized to receive the anabolic steroid oxymetholone [50 mg twice (BID) or three times daily (TID)] or placebo for 16 weeks followed by open-label treatment.

Oxymetholone led to a significant weight gain in the TID and BID groups (P<0.05 for each treatment versus placebo). Patients in the placebo group gained 1.0-kg compared to 3.0-kg among those receiving therapy three times daily and 3.5-kg among those receiving therapy twice daily. The most important adverse event was liver-associated toxicity. Overall, 35% of patients in the TID, 27% of patients in the BID oxymetholone group and no patients in the placebo group had a greater than five times baseline increase for alanine aminotransferase during the double-blind phase of the study. Two patients in the oxymetholone TID arm discontinued due to elevated liver enzymes.

Determinations of serum total testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) every 4 weeks during the 16-week studies were found to decrease markedly and significantly upon the intake of oxymetholone. All patients in the trial were eugonadal at the beginning of the trial. Total serum testosterone significantly declined in patients receiving oxymetholone BID or TID by 71% and 59%, respectively (each P<.0001). There was a parallel significant decline of LH and FSH, the regulators of testosterone production and gonadal function.
 
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