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Endocrine Treatment of Transsexual Persons Page 1 of 72 Title J Clin Endocrin Metab. First published ahead of print June 9, 2009 as doi:10.1210/jc.2009-0345 EndocrineTreatmentofTranssexualPersons Page1of72 Title: EndocrineTreatmentofTranssexualPersons:AnEndocrineSocietyClinicalPractice Guideline Short Title: GuidelinesontheEndocrineTreatmentofTranssexuals Authors: WylieC.Hembree,PeggyCohenKettenis,HenrietteA.DelemarrevandeWaal, LouisJ.Gooren,WalterJ.MeyerIII,NormanP.Spack,VinTangpricha,andVictorM.Montori Affiliations: ColumbiaUniversityandNewYorkPresbyterianHospital(W.C.H.),NewYork, NewYork; VrijeUniversityMedicalCenter(P.CK.),Amsterdam,TheNetherlands;Vrije UniversityMedicalCenter,AmsterdamandLeidenUniversityMedicalCenter(H.A.D.W.),The Netherlands;AndrogenConsultant(L.J.G.),Bangkok,Thailand;UniversityofTexasMedical Branch(W.J.M.),Galveston,Texas;HarvardMedicalSchool(N.P.S.),Boston,Massachusetts; EmoryUniversitySchoolofMedicine(V.T.),Atlanta,Georgia;andMayoClinic(V.M.M.), Rochester,Minnesota. Co-sponsoring Associations: EuropeanSocietyofEndocrinology(ESE),EuropeanSocietyof PediatricEndocrinology(ESPE),LawsonWilkinsPediatricEndocrineSociety(LWPES),and WorldProfessionalAssociationforTransgenderHealth(WPATH) Financial Disclosures of the Task Force: Wylie C. Hembree, M.D. (chair)—Financialor Business/OrganizationalInterests:ColumbiaUniversity,NewYorkPresbyterianHospital; SignificantFinancialInterestorLeadershipPosition:SpermBankofNewYork.Peggy Cohen- Kettenis, Ph.D.—FinancialorBusiness/OrganizationalInterests:nonedeclared;Significant FinancialInterestorLeadershipPosition:WPATH.Henriette A. Delemarre-van de Waal, Copyright (C) 2009 by The Endocrine Society EndocrineTreatmentofTranssexualPersons Page2of72 M.D., Ph.D.—FinancialorBusiness/OrganizationalInterests:nonedeclared;Significant FinancialInterestorLeadershipPosition:nonedeclared.Louis J. Gooren, M.D., Ph.D.— FinancialorBusiness/OrganizationalInterests:nonedeclared;SignificantFinancialInterestor LeadershipPosition:nonedeclared.Walter J. Meyer III, M.D.—Financialor Business/OrganizationalInterests:WPATH;SignificantFinancialInterestorLeadership Position:UniversityofTexasMedicalBranch,WPATH.Norman P. Spack, M.D.—Financialor Business/OrganizationalInterests:LWPES,AmericanDiabetesAssociation;Significant FinancialInterestorLeadershipPosition:nonedeclared.Vin Tangpricha, M.D., Ph.D.— FinancialorBusiness/OrganizationalInterests:Auxillium,Novartis,NIH;SignificantFinancial InterestorLeadershipPosition:nonedeclared.*Victor M. Montori, MDFinancialor Business/OrganizationalInterests:KERUnit(MayoClinic);SignificantFinancialInterestor LeadershipPosition:nonedeclared. *Evidence-based reviews for this guideline were prepared under contract with The Endocrine Society. Abstract Objective: Toformulatepracticeguidelinesfortheendocrinetreatmentoftranssexualpersons. Participants: AnEndocrineSocietyappointedTaskForceofexperts,amethodologist,anda medicalwriter. Evidence:ThisevidencebasedguidelinewasdevelopedusingtheGradingofRecommendations, Assessment,Development,andEvaluation(GRADE)systemtodescribeboththestrengthof recommendationsandthequalityofevidence,whichwasgenerallyloworverylow. EndocrineTreatmentofTranssexualPersons Page3of72 Consensus Process: Onegroupmeeting,severalconferencecalls,andemailcommunications enabledconsensus.CommitteesandmembersofTheEndocrineSociety,EuropeanSocietyof Endocrinology,theEuropeanSocietyforPaediatricEndocrinology(ESPE),WorldProfessional AssociationforTransgenderHealth(WPATH),andLawsonWilkinsPediatricEndocrineSociety reviewedandcommentedonpreliminarydraftsoftheseguidelines. Conclusions: (147 words) Sexreassignmentisamultidisciplinarytreatmentinwhichendocrinologistsplayanimportant role.Transsexualpersonsseekingtodevelopthephysicalcharacteristicsofthedesiredgender requireasafeandeffectivehormoneregimenthatwill1)suppressendogenoushormone secretiondeterminedbytheperson’sgenetic/biologicsexand2)maintainsexhormonelevels withinthenormalrangefortheperson’sgender.Amentalhealthprofessional(MHP)must recommendendocrinetreatmentandparticipateintheongoingcarethroughouttheendocrine transition.TheendocrinologistmustconfirmthediagnosticcriteriatheMHPusedtomakethis recommendationandcollaboratewiththeMHPinmakingtherecommendationforsurgicalsex reassignment.Werecommendtreatingtranssexualadolescents(Tannerstage2)withsuppression ofpubertywithGnRHanaloguesuntilage16years,afterwhichcrosssexhormonesmaybe given.Wesuggestsuppressionofendogenoussexhormones,maintainingphysiologiclevelsof genderappropriatesexhormonesandsurveillanceforknownrisksandcomplicationsinadult transsexualpersons. Number of Words, Number of Tables & Figures WordCount:8,610,Abstract:250,Tables:17,Figures:0 EndocrineTreatmentofTranssexualPersons Page4of72 Summary of Recommendations 1.0 DIAGNOSTIC PROCEDURE 1.1 We recommend that the diagnosis of gender identity disorder (GID) be made by a mental health professional. For children and adolescents the mental health professional should also have training in child and adolescent developmental psychopathology.(1| OO) 1.2 Given the high rate of remission of GID after the onset of puberty, we recommend against a complete social role change and hormone treatment in prepubertal children with GID. (1| OO) 1.3 We recommend that physicians evaluate and ensure that applicants understand the reversible and irreversible effects of hormone suppression (e.g., GnRH analogue treatment) and cross-sex hormone treatment before they start hormone treatment. 1.4 We recommend that all transsexual individuals be informed and counseled regarding options for fertility prior to initiation of puberty suppression in adolescents and prior to treatment with sex hormones of the desired sex in both adolescents and adults. 2.0 TREATMENT OF ADOLESCENTS 2.1. We recommend that adolescents who fulfill eligibility and readiness criteria for gender reassignment initially undergo treatment to suppress pubertal development. (1| OOO) 2.2. We recommend that suppression of pubertal hormones start when girls and boys first exhibit physical changes of puberty (confirmed by pubertal levels of estradiol and testosterone, respectively), but no earlier than Tanner stages 2-3. (1| OO) 2.3. We recommend that GnRH analogues be used to achieve suppression of pubertal hormones. (1| OO) 2.4. We suggest that pubertal development of the desired, opposite sex be initiated at about the age of 16 years, using a gradually increasing dose schedule of cross-sex steroids. (2| ) 2.5. We recommend referring hormone-treated adolescents for surgery when 1) the real life experience has resulted in a satisfactory social role change, 2) the individual is satisfied about the hormonal effects, and 3) the individual desires definitive surgical changes. (1| ) EndocrineTreatmentofTranssexualPersons Page5of72 2.6 We suggest deferring surgery until the individual is at least 18 years old. (2| ). 3.0 HORMONAL THERAPY FOR TRANSSEXUAL ADULTS 3.1 We recommend that treating endocrinologists confirm the diagnostic criteria of GID or transsexualism and the eligibility and readiness criteria for the endocrine phase of gender transition. (1| O) 3.2 We recommend that medical conditions that can be exacerbated by hormone depletion and cross-sex hormone treatment be evaluated and addressed prior to initiation of treatment (Table 11: Medical conditions that can be exacerbated by cross-sex hormone therapy). (1| O) 3.3 We suggest that cross-sex hormone levels be maintained in the normal physiologic range for the desired gender. (2| OO) 3.4 We suggest that endocrinologists review the onset and time course of physical changes induced by cross-sex hormone treatment. (2| OO) 4.0 ADVERSE OUTCOME PREVENTION AND LONG-TERM CARE 4.1 We suggest regular clinical and laboratory monitoring every 3 months during the first year and then once or twice yearly. (2| OO) 4.2 We suggest monitoring prolactin levels in male-to-female transsexual persons treated with estrogens. (2| OO) 4.3 We suggest that transsexual persons treated with hormones be evaluated for cardiovascular risk factors (2| OO) 4.4 We suggest that bone mineral density measurements be obtained if risk factors for osteoporosis exist, specifically in those who stop hormone therapy after gonadectomy. (2| O) 4.5 We suggest that male-to-female transsexual persons, who have no known increased risk of breast cancer, follow breast screening guidelines recommended for biological women. (2| OO) 4.6 We suggest that male-to-female transsexual persons treated with estrogens follow screening guidelines for prostatic disease and prostate cancer recommended for biological men. (2| OOO) EndocrineTreatmentofTranssexualPersons Page6of72 4.7 We suggest that female-to-male transsexual persons evaluate the risks and benefits of including total hysterectomy and oophorectomy as part of sex reassignment surgery. (2| OOO) 5.0 SURGERY FOR SEX REASSIGNMENT 5.1 We recommend that transsexual persons consider genital sex reassignment surgery only after both the physician responsible for endocrine transition therapy and the mental health professional find surgery advisable. (1| OOO) 5.2 We recommend that genital sex reassignment surgery be recommended only after completion of at least 1 year of consistent and compliant hormone treatment. (1| OOO) 5.3 We recommend that the physician responsible for endocrine treatment medically clear transsexual individuals for sex reassignment surgery and collaborate with the surgeon regarding hormone use during and after surgery. (1| OOO) EndocrineTreatmentofTranssexualPersons Page7of72 Introduction Menandwomenhaveexperiencedtheconfusionandanguishresultingfromrigid,forced conformitytosexualdimorphismthroughoutrecordedhistory.Aspectsofgendervariancehave
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