Treatment of pain in fibromyalgia patients with testosterone gel: Pharmacokinetics and clinical response.

Abstract To test our hypothesis that testosteronedeficiency plays an important role in chronic pain, a Phase I/II pilot study was initiated with 12 fibromyalgiapatients to verify that a daily dose for 28 days with transdermal testosteronegel would 1) significantly and safely increase mean serum testosteroneconcentrations from low baseline levels to mid/high-normal levels, and 2) effectively treat the pain and fatigue symptoms of fibromyalgia. Pharmacokinetic data confirmed that serum free testosteroneconcentrations were raised significantly above baseline levels, by assessment of maximum hormone concentration (C max ) and area underthe curve(AUC) parameters: free testosteroneC max was significantly raised from a mean of 2.64 pg/mL to 3.91 pg/mL (p