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J Clin Endocrinol Metab. 2014 Jul;99(7):E1287-93. doi: 10.1210/jc.2013-4160. Epub 2014 Apr 8.

Testosterone dose-response relationships with cardiovascular risk markers in androgen-deficient women: a randomized, placebo-controlled trial.

Author information

1
Section of Men's Health: Aging and Metabolism (G.H., M.D., H.S., T.G.T., S.Bh., S.Ba.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; and Department of Radiology (E.T., A.A., S.A., H.J.), Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts 02118.

Abstract

OBJECTIVE:

To determine dose-dependent effects of T administration on cardiovascular risk markers in women with low T levels.

METHODS:

Seventy-one hysterectomized women with or without oophorectomy with total T < 31 ng/dL and/or free T < 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were then randomized to receive weekly im injections of placebo or 3-, 6.25-, 12.5-, or 25-mg T enanthate for 24 weeks. Total and free T levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis, respectively. Insulin resistance and inflammatory markers were measured at baseline and 24 weeks. In a subset of women, magnetic resonance imaging of the abdomen was performed to quantify abdominal fat volume.

RESULTS:

Fifty-nine women who completed the 24-week intervention were included in the final analysis. The five groups were similar at baseline. Mean on-treatment nadir total T concentrations were 14, 79, 105, 130, and 232 ng/dL in the placebo group and the 3-, 6.25-, 12.5-, and 25-mg groups, respectively. No significant changes in fasting glucose, fasting insulin, homeostatic model assessment of insulin resistance, high sensitivity C-reactive protein, adiponectin, blood pressure, and heart rate were observed at any T dose when compared to placebo. Similarly, no dose- or concentration-dependent changes were observed in abdominal fat on magnetic resonance imaging.

CONCLUSION:

Short-term T administration over a wide range of doses for 24 weeks in women with low T levels was not associated with worsening of cardiovascular risk markers.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00494208.

PMID:
24712568
PMCID:
PMC4079305
DOI:
10.1210/jc.2013-4160
[Indexed for MEDLINE]
Free PMC Article

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