title: Treatment of pain in fibromyalgia patients with testosterone gel: Pharmacokinetics and clinical response.
abstract: To test our hypothesis that testosterone deficiency plays an important role in chronic pain, a Phase I/II pilot study was initiated with 12 fibromyalgia patients to verify that a daily dose for 28days with transdermal testosterone gel would 1) significantly and safely increase mean serum testosterone concentrations 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 testosterone concentrations were raised significantly above baseline levels, by assessment of maximum hormone concentration (Cmax) and area under the curve (AUC) parameters: free testosterone Cmax was significantly raised from a mean of 2.64pg/mL to 3.91pg/mL (p<0.05), and 24hour free testosterone AUC was significantly raised from a mean of 35.0pg-hr/mL to 53.89pg-hr/mL. Assessment of the typical symptoms of fibromyalgia by patient questionnaire and tender point exam demonstrated significant change in: decreased muscle pain, stiffness, and fatigue, and increased libido during study treatment. These results are consistent with the hypothesized ability of testosterone to relieve the symptoms of fibromyalgia. Symptoms not tightly related to fibromyalgia were not improved.
authors.affiliation: Department of Microbiology & Immunology, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH 03756, USA; White Mountain Pharma, 21 East 90th St, 8A, New York, NY 10128, USA. Electronic address: hillary.d.white@dartmouth.edu.
authors.forename: Hillary D
authors.initials: HD
authors.lastname: White
authors.affiliation: Department of Medicine, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH 03756, USA. Electronic address: lin.a.brown@hitchcock.org.
authors.forename: Lin A J
authors.initials: LA
authors.lastname: Brown
authors.affiliation: CPEX Pharmaceuticals, Inc., 1105 North Market St., Suite 1300, Wilmington, DE 19801, USA. Electronic address: bgyurik@comcast.net.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gyurik
authors.affiliation: Department of Obstetrics & Gynecology, Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. Electronic address: paul.d.manganiello@dartmouth.edu.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Manganiello
authors.affiliation: White Mountain Pharma, 21 East 90th St, 8A, New York, NY 10128, USA. Electronic address: drtomrobinson@aol.com.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Robinson
authors.affiliation: Department of Obstetrics & Gynecology, Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. Electronic address: linda.s.hallock@dartmouth.edu.
authors.forename: Linda S
authors.initials: LS
authors.lastname: Hallock
authors.affiliation: Department of Medicine, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH 03756, USA. Electronic address: lionel.lewis@dartmouth.edu.
authors.forename: Lionel D
authors.initials: LD
authors.lastname: Lewis
authors.affiliation: Department of Pathology, Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. Electronic address: jyeo@bsd.uchicago.edu.
authors.forename: Kiang-Teck J
authors.initials: KT
authors.lastname: Yeo
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D059350:Chronic Pain / Q000188:drug therapy* / Q000378:metabolism; D005221:Fatigue / Q000188:drug therapy / Q000378:metabolism; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy* / Q000378:metabolism; D005782:Gels; D006801:Humans; D007989:Libido / Q000187:drug effects; D008875:Middle Aged; D063806:Myalgia / Q000188:drug therapy / Q000378:metabolism; D010865:Pilot Projects; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D005782:Gels; D013739:Testosterone
keywords: Chronic pain; Fibromyalgia; Nociception; Pharmacokinetics; Testosterone