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Short-term testosterone therapy failed to increase CV risk in women
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In women with low testosterone levels, a short-term regimen of testosterone treatment over a wide range of doses did not appear to increase cardiovascular risk, according to findings from the Testosterone Dose Response in Surgically Menopausal Women trial.
In the double blind, placebo-controlled study, researchers evaluated 71 women who had undergone hysterectomy with or without oophorectomy, and who had total testosterone levels lower than 31 ng/dL and free testosterone levels lower than 3.5 pg/mL. During a 12-week run-in phase, all participants underwent a regimen of transdermal estradiol applied twice weekly in patch form. The goal of this regimen was to achieve daily delivery of 50 mcg estradiol.
After the run-in period, study participants were randomly assigned to weekly intramuscular injection with placebo or with 3 mg, 6.25 mg, 12.5 mg or 25 mg testosterone enanthate for 24 weeks. The researchers used liquid chromatography-tandem mass spectroscopy (LC-MS), with sensitivity levels of 2 ng/dL, to measure total serum testosterone levels. Equilibrium dialysis was used to determine free testosterone levels. Measurement of fasting insulin levels was taken using radioimmunoassay, and glucose levels were assessed using a glucose oxidase method. The homeostatic model assessment (HOMA) index was utilized to evaluate insulin resistance, and ELISA tests were utilized to measure adiponectin and high-sensitivity C-reactive protein (CRP). Blood pressure and heart rate measurements were taken, and abdominal fat was measured by MRI.
Fifty-four participants remained in the study until the completion of the 24-week regimen. The five groups had similar measurements at baseline. After treatment, the mean lowest total testosterone concentrations were as follows: 14 ng/dL in the placebo group; 79 ng/dL in the 3-mg testosterone group, 105 ng/dL in the 6.25-mg group, 130 ng/dL in the 12.5-mg group and 232 ng/dL in the 25-mg group. There were no significant differences in fasting glucose, fasting insulin, HOMA insulin resistance, high-sensitivity CRP, adiponectin, BP or heart rate.
“Short-term testosterone administration over a wide range for 24 weeks in hysterectomized women was not associated with the worsening of cardiovascular risk markers,” the researchers said. “The cardiovascular safety of testosterone therapy in women needs further investigation in long-term, adequately powered trials.”
Disclosure: Two researchers reported financial ties to Abbott Pharmaceuticals and Eli Lilly and Co.
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