Safety and efficacy of testosterone gel in the treatment of male hypogonadism

References

• AraujoABO’DonnellABBrambillaDJPrevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging StudyJ Clin Endocrinol Metab200489125920592615579737
   PubMed Web of Science ®Google Scholar
• HarmanSMMetterEJTobinJDPearsonJBlackmanMRLongitudinal effects of aging on serum total and free testosterone levels in healthy men Baltimore Longitudinal Study of AgingJ Clin Endocrinol Metab200186272473111158037
   PubMed Web of Science ®Google Scholar
• AraujoABEscheGRKupelianVPrevalence of symptomatic androgen deficiency in menJ Clin Endocrinol Metab200792114241424717698901
   PubMed Web of Science ®Google Scholar
• PetakSMNankinHRSparkRFSwerdloffRSRodriguez-RigauLJAmerican Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients – 2002 updateEndocr Pract20028644045615260010
   PubMedGoogle Scholar
• BhasinSCunninghamGRHayesFJTestosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guidelineJ Clin Endocrinol Metab20069161995201016720669
   PubMed Web of Science ®Google Scholar
• WangCNieschlagESwerdloffRInvestigation, treatment and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA and ASA recommendationsEur J Endocrinol2008159550751418955511
   PubMed Web of Science ®Google Scholar
• ZitzmannMFaberSNieschlagEAssociation of specific symptoms and metabolic risks with serum testosterone in older menJ Clin Endocrinol Metab200691114335434316926258
   PubMed Web of Science ®Google Scholar
• KelleherSConwayAJHandelsmanDJBlood testosterone threshold for androgen deficiency symptomsJ Clin Endocrinol Metab20048983813381715292310
   PubMed Web of Science ®Google Scholar
• VermeulenAVerdonckLKaufmanJMA critical evaluation of simple methods for the estimation of free testosterone in serumJ Clin Endocrinol Metab199984103666367210523012
   PubMed Web of Science ®Google Scholar
• SödergardRBackstromTShanbhagVCarstensenHCalculation of free and bound fractions of testosterone and estradiol-17 beta to human plasma proteins at body temperatureJ Steroid Biochem19821668018107202083
   PubMedGoogle Scholar
• RosnerWAuchusRJAzzizRSlussPMRaffHPosition statement: Utility, limitations, and pitfalls in measuring testosterone: an Endocrine Society position statementJ Clin Endocrinol Metab2200792240541317090633
   PubMed Web of Science ®Google Scholar
• SimmerHSIArnold Adolph Berthold (1803–1861) Zur Erinnerung an den hundertsten Todestag des Begrunders der experimentellenEndokrinologie Dtsch med Wschr19618621862192
   Web of Science ®Google Scholar
• CussonsAJBhagatCIFletcherSJWalshJPBrown-Sequard revisited: a lesson from history on the placebo effect of androgen treatmentMed J Aust2002177111267867912088472
   PubMed Web of Science ®Google Scholar
• VornoffSTesticular grafting from ape to manLondon, UKBrentanos Ltd1920
   Google Scholar
• NieschlagEBehreHMNieschlagSTestosterone: Action, deficiency, substitutionCambridge, MACambridge University Press200414405406
   Google Scholar
• JunkmanKUber protrahiert wirksame androgeneArch Path Pharmacol19522158592
   Google Scholar
• NiechlagEMaussJCoertAKicovicPPlasma androgen levels in men after oral administration of testosterone or testosterone undecanoateActa Endocrinol1975793663741173495
   PubMedGoogle Scholar
• Bals-PratschMKnuthUAYoonYDNieschlagETransdermal testosterone substitution therapy for male hypogonadismLancet1986285139439462877131
   PubMed Web of Science ®Google Scholar
• MazerNAHeiberWEMoellmerJFEnhanced transdermal delivery of testosterone: a new physiological approach for androgen replacement in hypogonadal menJ Control Release199219347362
   Google Scholar
• WangCBermanNLongstrethJAPharmacokinetics of transdermal testosterone gel in hypogonadal men: application of gel at one site versus four sites: a General Clinical Research Center StudyJ Clin Endocrinol Metab200085396496910720024
   PubMed Web of Science ®Google Scholar
• NieschlagEBuchterDVon EckardsteinSAbshagenKSimoniMBehreHMRepeated intramuscular injections of testosterone undecanoate for substitution therapy in hypogonadal menClin Endocrinol (Oxf)199951675776310619981
   PubMed Web of Science ®Google Scholar
• Unimed-Pharmaceuticals IncA Solvay Pharmaceuticals I, CompanyAndroGel prescribing information for healthcare professionalsMarietta, GASolvay Pharmaceuticals, Inc2004
   Google Scholar
• Auxilium Pharmaceuticals ITestim prescribing information for healthcare professionalsNorristown, PAAuxilium Pharmaceuticals2004
   Google Scholar
• Sitruk-WareRTransdermal delivery of steroidsContraception19893911202642780
   PubMed Web of Science ®Google Scholar
• SwerdloffRSWangCCunninghamGLong-term pharmaco-kinetics of transdermal testosterone gel in hypogonadal menJ Clin Endocrinol Metab200085124500451011134099
   PubMed Web of Science ®Google Scholar
• WangCCunninghamGDobsALong-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal menJ Clin Endocrinol Metab20048952085209815126525
   PubMed Web of Science ®Google Scholar
• McNicholasTADeanJDMulderHCarnegieCJonesNAA novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual functionBJU Int2003911697412614254
   PubMed Web of Science ®Google Scholar
• KuhnertBByrneMSimoniMTestosterone substitution with a new transdermal, hydroalcoholic gel applied to scrotal or non-scrotal skin: a multicentre trialEur J Endocrinol2005153231732616061839
   PubMed Web of Science ®Google Scholar
• SteidleCSchwartzSJacobyKSebreeTSmithTBachandRAA2500 Testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual functionJ Clin Endocrinol Metab20038862673268112788872
   PubMed Web of Science ®Google Scholar
• DeanJDCarnegieCRodzvillaJSmithTLong-term effects of testim(r) 1% testosterone gel in hypogonadal menRev Urol20046Suppl 6S22S2916985908
   PubMedGoogle Scholar
• MazerNBellDWuJFischerJCosgroveMEilersBComparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal menJ Sex Med20052221322616422889
   PubMed Web of Science ®Google Scholar
• ScottJDWolfePRAndersonPCohanGRScarsellaAProspective study of topical testosterone gel (AndroGel) versus intramuscular testosterone in testosterone-deficient HIV-infected menHIV Clin Trials20078641242018042506
   PubMed Web of Science ®Google Scholar
• MarburyTHamillEBachandRSebreeTSmithTEvaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGelBiopharm Drug Dispos200324311512012673669
   PubMed Web of Science ®Google Scholar
• BhasinSCalofOMStorerTWDrug insight: Testosterone and selective androgen receptor modulators as anabolic therapies for chronic illness and agingNat Clin Pract Endocrinol Metab20062314615916932274
   PubMedGoogle Scholar
• SinghRArtazaJNTaylorWETestosterone inhibits adipogenic differentiation in 3T3-L1 cells: nuclear translocation of androgen receptor complex with beta-catenin and T-cell factor 4 may bypass canonical Wnt signaling to down-regulate adipogenic transcription factorsEndocrinology2006147114115416210377
   PubMed Web of Science ®Google Scholar
• BrodskyIGBalagopalPNairKSEffects of testosterone replacement on muscle mass and muscle protein synthesis in hypogonadal men – a clinical research center studyJ Clin Endocrinol Metab19968110346934758855787
   PubMed Web of Science ®Google Scholar
• FerrandoAASheffield-MooreMYeckelCWTestosterone administration to older men improves muscle function: molecular and physiological mechanismsAm J Physiol Endocrinol Metab20022823E601E60711832363
   PubMed Web of Science ®Google Scholar
• CesariMPenninxBWPahorMInflammatory markers and physical performance in older persons: the InCHIANTI studyJ Gerontol A Biol Sci Med Sci200459324224815031308
   PubMed Web of Science ®Google Scholar
• KapoorDClarkeSStanworthRChannerKSJonesTHThe effect of testosterone replacement therapy on adipocytokines and C-reactive protein in hypogonadal men with type 2 diabetesEur J Endocrinol2007156559560217468196
   PubMed Web of Science ®Google Scholar
• MaggioMBasariaSBleACorrelation between testosterone and the inflammatory marker soluble interleukin-6 receptor in older menJ Clin Endocrinol Metab200691134534716263825
   PubMed Web of Science ®Google Scholar
• PageSTHerbstKLAmoryJKTestosterone administration suppresses adiponectin levels in menJ Androl2005261859215611571
   PubMedGoogle Scholar
• WangCSwerdloffRSIranmaneshATestosterone Gel Study GroupTransdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal menJ Clin Endocrinol Metab20008582839285310946892
   PubMed Web of Science ®Google Scholar
• SteidleCWittMAMatriscianoJBlockJESexual functioning and satisfaction in nonresponders to testosterone gel: Potential effectiveness of retreatment in hypogonadal malesClin Cornerstone20057Suppl 4S20S2516651204
   PubMedGoogle Scholar
• ColvardDSEriksenEFKeetingPEIdentification of androgen receptors in normal human osteoblast-like cellsProc Natl Acad Sci U S A19898638548572915981
   PubMed Web of Science ®Google Scholar
• PedersonLKremerMJuddJAndrogens regulate bone resorption activity of isolated osteoclasts in vitroProc Natl Acad Sci U S A19999625055109892663
   PubMed Web of Science ®Google Scholar
• ChenQKajiHSugimotoTChiharaKTestosterone inhibits osteoclast formation stimulated by parathyroid hormone through androgen receptorFEBS Lett20014911–2919311226426
   PubMed Web of Science ®Google Scholar
• KhoslaSMinireview: the OPG/RANKL/RANK systemEndocrinology2001142125050505511713196
   PubMed Web of Science ®Google Scholar
• BoyceBFXingLFunctions of RANKL/RANK/OPG in bone modeling and remodelingArch Biochem Biophys2008473213914618395508
   PubMed Web of Science ®Google Scholar
• HofbauerLCTenRMKhoslaSThe anti-androgen hydroxyflutamide and androgens inhibit interleukin-6 production by an androgen-responsive human osteoblastic cell lineJ Bone Miner Res19991481330133710457265
   PubMed Web of Science ®Google Scholar
• PilbeamCCRaiszLGEffects of androgens on parathyroid hormone and interleukin-1-stimulated prostaglandin production in cultured neonatal mouse calvariaeJ Bone Miner Res1990511118311882270781
   PubMed Web of Science ®Google Scholar
• LederBZFinkelsteinJSEffect of aromatase inhibition on bone metabolism in elderly hypogonadal menOsteoporos Int200516121487149415856361
   PubMed Web of Science ®Google Scholar
• WangCSwerdloffRSIranmaneshAEffects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal menClin Endocrinol (Oxf)200154673975011422108
   PubMed Web of Science ®Google Scholar
• NieschlagEBehreHMTestosterone: Action, Deficiency, SubstitutionCambridge, MACambridge University Press2004
   Google Scholar
• LoizidesESwierzewskiMJO’NeillCGriesserJSmithTEarly response time in sexual activity and mood following testosterone gel replacement in hypogonadal males from the Testim(R) START StudyRev Urol20046Suppl 6S16S2116985907
   PubMedGoogle Scholar
• BhasinSWoodhouseLCasaburiRTestosterone dose-response relationships in healthy young menAm J Physiol Endocrinol Metab20012816E1172E118111701431
   PubMed Web of Science ®Google Scholar
• SeftelADMackRJSecrestARSmithTMRestorative increases in serum testosterone levels are significantly correlated to improvements in sexual functioningJ Androl200425696397215477371
   PubMedGoogle Scholar
• ShabsighRKaufmanJMSteidleCPadma-NathanHRandomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil aloneJ Urol20081795 SupplS97S10218405769
   PubMed Web of Science ®Google Scholar
• MeikleAWArverSDobsASProstate size in hypogonadal men treated with a nonscrotal permeation-enhanced testosterone transdermal systemUrology19974921911969037280
   PubMed Web of Science ®Google Scholar
• de RondeWHyperandrogenism after transfer of topical testosterone gel: case report and review of published and unpublished studiesHum Reprod200924242542818948313
   PubMed Web of Science ®Google Scholar
• Food and Drug AdministrationTestosterone gel safety concerns prompt FDA to require label changes, medication guide. Available from: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html
   Google Scholar
• SchraderSMillsAScheperleMBlockJEImprovement in sexual functioning and satisfaction in nonresponders to testosterone gel: clinical effectiveness in hypogonadal, HIV-positive malesClin Cornerstone20057Suppl 4S26S3116651205
   PubMedGoogle Scholar
• GroberEDKheraMSoniSDEspinozaMGLipshultzLIEfficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal menInt J Impot Res200820221321717898800
   PubMed Web of Science ®Google Scholar
• NieschlagECuppersHJWiegelmannWWickingsEJBioavailability and LH-suppressing effect of different testosterone preparations in normal and hypogonadal menHorm Res1976731381451002121
   PubMedGoogle Scholar
• SnyderPJLawrenceDATreatment of male hypogonadism with testosterone enanthateJ Clin Endocrinol Metab1980516133513396777395
   PubMed Web of Science ®Google Scholar
• PartschCJWeinbauerGFFangRNieschlagEInjectable testosterone undecanoate has more favourable pharmacokinetics and pharmacodynamics than testosterone enanthateEur J Endocrinol199513245145197711892
   PubMed Web of Science ®Google Scholar
• SchubertMMinnemannTHublerDIntramuscular testosterone undecanoate: pharmacokinetic aspects of a novel testosterone formulation during long-term treatment of men with hypogonadismJ Clin Endocrinol Metab200489115429543415531493
   PubMed Web of Science ®Google Scholar
• MinnemannTSchubertMFreudeSComparison of a new long-acting testosterone undecanoate formulation vs testosterone enanthate for intramuscular androgen therapy in male hypogonadismJ Endocrinol Invest200831871872318852533
   PubMed Web of Science ®Google Scholar