title: Serum Testosterone (T) Level Variability in T Gel-Treated Older Hypogonadal Men: Treatment Monitoring Implications.
abstract: BACKGROUND
  The optimal frequency for on-treatment serum T measurement used for dose adjustment after transdermal T gel application is unknown, especially in older men with thinner skin and slower metabolic clearance.
  
  
  OBJECTIVE
  The objectives of the study was to determine the variability of postgel application serum T concentrations and assess whether single levels are reflective of average serum T concentrations over 24 hours (Cavg0-24).
  
  
  METHODS
  This was a double-blinded, placebo-controlled randomized trial.
  
  
  METHODS
  The study was conducted at five academic centers.
  
  
  METHODS
  Forty-seven symptomatic men 65 years old or older with an average of two morning T concentration less than 275 ng/dL participated in the study.
  
  
  METHODS
  Transdermal T or placebo gel was applied for 120 ± 14 days. Monthly dose adjustments were made if necessary to target serum T between 400 and 500 to 800 ng/dL.
  
  
  METHODS
  Variability of serum T 2 hours after the gel application on two outpatient visits and at multiple time points over 24 hours during the inpatient day was measured.
  
  
  RESULTS
  On-treatment T levels varied substantially on the 2 ambulatory days and over 24 hours during the inpatient day. Ambulatory 2-hour postapplication T levels did not correlate significantly with either 2-hour postapplication serum T or Cavg0-24 measured during the inpatient day. Only 22.2% of men receiving T had a Cavg0-24 within the target range of 500-800 ng/dL; 81.5% had a Cavg0-24 within the broader 300-1000 ng/dL range.
  
  
  CONCLUSIONS
  Large within-individual variations in serum T after T gel application render ambulatory 2-hour postapplication T level a poor indicator of average serum T on another day. Our data point out the limitations of dose adjustments based on a single postapplication serum T measurement.
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Swerdloff
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Youngju
authors.initials: Y
authors.lastname: Pak
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Christina
authors.initials: C
authors.lastname: Wang
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Peter Y
authors.initials: PY
authors.lastname: Liu
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Shalender
authors.initials: S
authors.lastname: Bhasin
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Gill
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Alvin M
authors.initials: AM
authors.lastname: Matsumoto
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Marco
authors.initials: M
authors.lastname: Pahor
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Prasanth
authors.initials: P
authors.lastname: Surampudi
authors.affiliation: Division of Endocrinology (R.S.S., Y.P., C.W., P.Y.L., P.S.), Department of Medicine, and the Clinical and Translational Science Institute (Y.P., C.W.), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509; The Research Program in Men's Health: Aging and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Yale University (T.M.G.), New Haven, Connecticut 06510; Division of Gerontology and Geriatric Medicine (A.M.M.), Department of Medicine, University of Washington, and Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System (A.M.M.), Seattle, Washington 98108; Department of Aging and Geriatric Research (M.P.), University of Florida, Gainesville, Florida 32611; and Division of Endocrinology (P.J.S.), Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104-5160.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Snyder
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005782:Gels; D006801:Humans; D007006:Hypogonadism / Q000097:blood* / Q000188:drug therapy*; D008297:Male; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005782:Gels; D013739:Testosterone