Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons

35 Pages·2017·0.49 MB·English

C L I N I C A L P R A C T I C E G U I D E L I N E
Endocrine Treatment of Gender-Dysphoric/
Gender-Incongruent Persons: An Endocrine Society*
Clinical Practice Guideline
Wylie C. Hembree,1 Peggy T. Cohen-Kettenis,2 Louis Gooren,3 Sabine E. Hannema,4
Walter J. Meyer,5 M. Hassan Murad,6 Stephen M. Rosenthal,7 Joshua D. Safer,8
Vin Tangpricha,9 and Guy G. T’Sjoen,10
1NewYorkPresbyterianHospital,ColumbiaUniversityMedicalCenter,NewYork,NewYork10032
(Retired);2VUUniversityMedicalCenter,1007MBAmsterdam,Netherlands(Retired);3VUUniversity
MedicalCenter,1007MBAmsterdam,Netherlands(Retired);4LeidenUniversityMedicalCenter,2300RC
Leiden,Netherlands;5UniversityofTexasMedicalBranch,Galveston,Texas77555;6MayoClinicEvidence-
BasedPracticeCenter,Rochester,Minnesota55905;7UniversityofCaliforniaSanFrancisco,Benioff
Children’sHospital,SanFrancisco,California94143;8BostonUniversitySchoolofMedicine,Boston,
Massachusetts02118;9EmoryUniversitySchoolofMedicineandtheAtlantaVAMedicalCenter,Atlanta,
Georgia30322;and10GhentUniversityHospital,9000Ghent,Belgium
*Cosponsoring Associations: American Association of Clinical Endo-
crinologists, American Society of Andrology, European Society for
Pediatric Endocrinology, European Society of Endocrinology, Pedi-
atric Endocrine Society, and World Professional Association for
TransgenderHealth.
Objective: To update the “Endocrine Treatment of Transsexual Persons: An Endocrine Society
ClinicalPracticeGuideline,”publishedbytheEndocrineSocietyin2009.
Participants:TheparticipantsincludeanEndocrineSociety–appointedtaskforceofnineexperts,a
methodologist,andamedicalwriter.
Evidence:Thisevidence-basedguidelinewasdevelopedusingtheGradingofRecommendations,
Assessment,Development,andEvaluationapproachtodescribethestrengthofrecommendations
andthequalityofevidence.Thetaskforcecommissionedtwosystematicreviewsandusedthebest
availableevidencefromotherpublishedsystematicreviewsandindividualstudies.
Consensus Process: Group meetings, conference calls, and e-mail communications enabled
consensus. Endocrine Society committees, members and cosponsoring organizations reviewed
andcommentedonpreliminarydraftsoftheguidelines.
Conclusion: Gender affirmation is multidisciplinary treatment in which endocrinologists play an
important role. Gender-dysphoric/gender-incongruent persons seek and/or are referred to
endocrinologists to develop the physical characteristics of the affirmed gender. They require a
safe and effective hormone regimen that will (1) suppress endogenous sex hormone
secretion determined by the person’s genetic/gonadal sex and (2) maintain sex hormone
levelswithinthenormalrangefortheperson’saffirmed gender. Hormonetreatment isnot
recommended for prepubertal gender-dysphoric/gender-incongruent persons. Those clinicians
who recommend gender-affirming endocrine treatments—appropriately trained diagnosing
clinicians (required), a mental health provider for adolescents (required) and mental health
ISSNPrint0021-972X ISSNOnline1945-7197 Abbreviations:BMD,bonemineraldensity;DSD,disorder/differenceofsexdevelopment;
PrintedinUSA DSM,DiagnosticandStatisticalManualofMentalDisorders;GD,genderdysphoria;
Copyright©2017EndocrineSociety GnRH,gonadotropin-releasinghormone;ICD,InternationalStatisticalClassificationof
Received24July2017.Accepted24August2017. DiseasesandRelatedHealthProblems;MHP,mentalhealthprofessional;VTE,venous
FirstPublishedOnline13September2017 thromboembolism.
doi:10.1210/jc.2017-01658 JClinEndocrinolMetab,November2017,102(11):1–35 https://academic.oup.com/jcem 1
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2 Hembreeetal GuidelinesonGender-Dysphoric/Gender-IncongruentPersons JClinEndocrinolMetab,November2017,102(11):1–35
professionalforadults(recommended)—shouldbeknowledgeableaboutthediagnosticcriteria
andcriteriaforgender-affirmingtreatment,havesufficienttrainingandexperienceinassessing
psychopathology, and be willing to participate in the ongoing care throughout the endocrine
transition.Werecommendtreatinggender-dysphoric/gender-incongruentadolescentswhohave
entered puberty at Tanner Stage G2/B2 by suppression with gonadotropin-releasing hormone
agonists. Clinicians may add gender-affirming hormones after a multidisciplinary team has
confirmed the persistence of gender dysphoria/gender incongruence and sufficient mental
capacity to give informed consent to this partially irreversible treatment. Most adolescents
havethiscapacitybyage16yearsold.Werecognizethattheremaybecompellingreasonsto
initiate sex hormone treatment prior to age 16 years, although there is minimal published
experience treating prior to 13.5 to 14 years of age. For the care of peripubertal youths and
older adolescents, we recommend that an expert multidisciplinary team comprised of medical
professionals and mental health professionals manage this treatment. The treating physician
must confirm the criteria for treatment used by the referring mental health practitioner and
collaboratewiththemindecisionsaboutgender-affirmingsurgeryinolderadolescents.Foradult
gender-dysphoric/gender-incongruentpersons,thetreatingclinicians(collectively)shouldhave
expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone
treatment, and surgery, as needed by the patient. We suggest maintaining physiologic
levels of gender-appropriate hormones and monitoring for known risks and complications.
When high doses of sex steroids are required to suppress endogenous sex steroids and/or in
advancedage,cliniciansmayconsidersurgicallyremovingnatalgonadsalongwithreducingsex
steroid treatment. Clinicians should monitor both transgender males (female to male) and
transgenderfemales(maletofemale)forreproductiveorgancancerriskwhensurgicalremoval
isincomplete.Additionally,cliniciansshouldpersistentlymonitoradverseeffectsofsexsteroids.For
gender-affirmingsurgeriesinadults,thetreatingphysicianmustcollaboratewithandconfirmthe
criteriafortreatmentusedbythereferringphysician.Cliniciansshouldavoidharmingindividuals(via
hormonetreatment)whohaveconditionsotherthangenderdysphoria/genderincongruenceand
whomay notbenefitfromthephysicalchangesassociatedwiththis treatment.(JClinEndocrinol
Metab102:1–35,2017)
Summary of Recommendations 1.2. We advise that only MHPs who meet the fol-
lowing criteria should diagnose GD/gender in-
1.0 Evaluation of youth and adults
congruence in children and adolescents: (1)
1.1. We advise that only trained mental health pro- training in child and adolescent developmental
fessionals (MHPs) who meet the following cri- psychologyandpsychopathology,(2)competence
teria should diagnose gender dysphoria (GD)/ in using the DSM and/or the ICD for diagnostic
gender incongruence in adults: (1) competence purposes, (3) the ability to make a distinction
in using the Diagnostic and Statistical Manual betweenGD/genderincongruenceandconditions
of Mental Disorders (DSM) and/or the In- thathavesimilarfeatures(e.g.,bodydysmorphic
ternational Statistical Classification of Diseases disorder), (4) training in diagnosing psychiatric
and Related Health Problems (ICD) for di- conditions,(5)theabilitytoundertakeorreferfor
agnosticpurposes,(2)theabilitytodiagnoseGD/ appropriate treatment, (6) the ability to psycho-
gender incongruence and make a distinction socially assess the person’s understanding and
betweenGD/genderincongruenceandconditions socialconditionsthatcanimpactgender-affirming
thathavesimilarfeatures(e.g.,bodydysmorphic hormone therapy, (7) a practice of regularly at-
disorder), (3) training in diagnosing psychiatric tending relevant professional meetings, and (8)
conditions, (4) the ability to undertake or refer knowledgeofthecriteriaforpubertyblockingand
for appropriate treatment, (5) the ability to gender-affirming hormone treatment in adoles-
psychosociallyassesstheperson’sunderstanding, cents.(Ungraded Good Practice Statement)
mental health, and social conditions that can 1.3. We advise that decisions regarding the social
impact gender-affirming hormone therapy, and transitionofprepubertalyouthswithGD/gender
(6) a practice of regularly attending relevant incongruence are made with the assistance of
professionalmeetings.(UngradedGoodPractice an MHP or another experienced professional.
Statement) (Ungraded Good Practice Statement).
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1.4. We recommend against puberty blocking and the criteria for the endocrine phase of gender
gender-affirming hormone treatment in pre- transitionbeforebeginningtreatment.(1|(cid:1)(cid:1)(cid:1)s)
pubertalchildrenwithGD/genderincongruence. 3.2. We recommend that clinicians evaluate and ad-
(1 |(cid:1)(cid:1)ss) dressmedicalconditionsthatcanbeexacerbated
1.5. We recommend that clinicians inform and by hormone depletion and treatment with sex
counsel all individuals seeking gender-affirming hormones of the affirmed gender before begin-
medical treatment regarding options for fertility ning treatment. (1 |(cid:1)(cid:1)(cid:1)s)
preservation prior to initiating puberty sup- 3.3. We suggest that clinicians measure hormone
pressioninadolescentsandpriortotreatingwith levels during treatment to ensure that endog-
hormonaltherapyoftheaffirmedgenderinboth enous sex steroids are suppressed and admin-
adolescents and adults. (1 |(cid:1)(cid:1)(cid:1)s) istered sex steroids are maintained in the
normal physiologic range for the affirmed
gender. (2 |(cid:1)(cid:1)ss)
2.0 Treatment of adolescents
3.4. We suggest that endocrinologists provide edu-
2.1. Wesuggestthatadolescentswhomeetdiagnostic cation to transgender individuals undergoing
criteria for GD/gender incongruence, fulfill cri- treatment about the onset and time course of
teriafortreatment,andarerequestingtreatment physical changes induced by sex hormone
should initially undergo treatment to suppress treatment. (2 |(cid:1)sss)
pubertal development. (2 |(cid:1)(cid:1)ss)
2.2. We suggest that clinicians begin pubertal hor-
4.0Adverseoutcomepreventionandlong-termcare
monesuppressionaftergirlsandboysfirstexhibit
physical changes of puberty. (2 |(cid:1)(cid:1)ss) 4.1. We suggest regular clinical evaluation for phys-
2.3. We recommend that, where indicated, GnRH ical changes and potential adverse changes in
analogues are used to suppress pubertal hor- responsetosexsteroidhormonesandlaboratory
mones. (1 |(cid:1)(cid:1)ss) monitoring of sex steroid hormone levels every
2.4. In adolescents who request sex hormone treat- 3 months during the first year of hormone
ment(giventhisisapartlyirreversibletreatment), therapy for transgender males and females and
we recommend initiating treatment using a then once or twice yearly. (2 |(cid:1)(cid:1)ss)
gradually increasing dose schedule after a mul- 4.2. We suggest periodically monitoring prolactin
tidisciplinary team of medical and MHPs has levels in transgender females treated with estro-
confirmed the persistence of GD/gender in- gens. (2 |(cid:1)(cid:1)ss)
congruenceandsufficientmentalcapacitytogive 4.3. We suggest that clinicians evaluate transgender
informed consent, which most adolescents have persons treated with hormones for cardiovas-
by age 16 years. (1 |(cid:1)(cid:1)ss). cular risk factors using fasting lipid profiles, di-
2.5. We recognize that there may be compelling abetes screening, and/or other diagnostic tools.
reasons to initiate sex hormone treatment prior (2 |(cid:1)(cid:1)ss)
totheageof16yearsinsomeadolescentswithGD/ 4.4. We recommend that clinicians obtain bone
gender incongruence, even though there are mineraldensity(BMD)measurementswhenrisk
minimal published studies of gender-affirming factorsforosteoporosisexist,specificallyinthose
hormonetreatmentsadministeredbeforeage13.5 who stop sex hormone therapy after gonadec-
to 14 years. As with the care of adolescents tomy. (1 |(cid:1)(cid:1)ss)
$16 years of age, we recommend that an ex- 4.5. We suggest that transgender females with no
pert multidisciplinary team of medical and known increased risk of breast cancer follow
MHPs manage this treatment. (1 |(cid:1)sss) breast-screening guidelines recommended for
2.6. We suggest monitoring clinical pubertal devel- non-transgender females. (2 |(cid:1)(cid:1)ss)
opment every 3 to 6 months and laboratory 4.6. We suggest that transgender females treated
parameters every 6 to 12 months during sex withestrogens follow individualized screening
hormone treatment. (2 |(cid:1)(cid:1)ss) according to personal risk for prostatic disease
and prostate cancer. (2 |(cid:1)sss)
4.7. We advise that clinicians determine the medical
3.0 Hormonal therapy for transgender adults
necessity of including a total hysterectomy and
3.1. We recommend that clinicians confirm the di- oophorectomy as part of gender-affirming sur-
agnostic criteria of GD/gender incongruence and gery. (Ungraded Good Practice Statement)
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4 Hembreeetal GuidelinesonGender-Dysphoric/Gender-IncongruentPersons JClinEndocrinolMetab,November2017,102(11):1–35
5.0 Surgery for sex reassignment and clinicalevaluationofbothyouthandadults,definesin
gender confirmation detailthe professional qualifications required of those
who diagnose and treat both adolescents and adults.
5.1. We recommend that a patient pursue genital
Weadvisethatdecisionsregardingthesocialtransition
gender-affirmingsurgeryonlyaftertheMHPand
ofprepubertalyoutharemadewiththeassistanceofa
theclinicianresponsibleforendocrinetransition
mental health professional or similarly experienced
therapy both agree that surgery is medically
professional.Werecommendagainstpubertyblocking
necessaryandwouldbenefitthepatient’soverall
followed by gender-affirming hormone treatment of pre-
health and/or well-being. (1 |(cid:1)(cid:1)ss)
pubertal children. Clinicians should inform pubertal
5.2. Weadvisethatcliniciansapprovegenitalgender-
children, adolescents, and adults seeking gender-
affirmingsurgeryonlyaftercompletionofatleast
confirming treatment of their options for fertility preser-
1 year of consistent and compliant hormone
vation. Prior to treatment, clinicians should evaluate the
treatment,unlesshormonetherapyisnotdesired
presence of medical conditions that may be worsened
or medically contraindicated. (Ungraded Good
by hormone depletion and/or treatment. A multidis-
Practice Statement)
ciplinary team, preferably composed of medical and
5.3. We advise that the clinician responsible for en-
mental health professionals, should monitor treat-
docrinetreatmentandtheprimarycareprovider
ments. Clinicians evaluating transgender adults for
ensure appropriate medical clearance of trans-
endocrine treatment should confirm the diagnosis of
gender individuals for genital gender-affirming
persistent gender dysphoria/gender incongruence.
surgery and collaborate with the surgeon re-
Physicians should educate transgender persons re-
garding hormone use during and after surgery.
garding the time course of steroid-induced physical
(Ungraded Good Practice Statement)
changes.Treatmentshouldincludeperiodicmonitoringof
5.4. We recommend that clinicians refer hormone-
hormone levels and metabolic parameters, as well as as-
treated transgender individuals for genital sur-
sessmentsofbonedensityandtheimpactuponprostate,
gerywhen:(1)theindividualhashadasatisfactory
gonads,anduterus.Wealsomakerecommendationsfor
social role change, (2) the individual is satisfied
transgender persons who plan genital gender-affirming
aboutthehormonaleffects,and(3)theindividual
surgery.
desires definitive surgicalchanges. (1|(cid:1)sss)
5.5. Wesuggestthatcliniciansdelaygender-affirming
MethodofDevelopmentofEvidence-Based
genital surgery involving gonadectomy and/or
Clinical Practice Guidelines
hysterectomy until the patient is at least 18
years old or legal age of majority in his or her
TheClinicalGuidelinesSubcommittee(CGS)oftheEndocrine
country. (2 |(cid:1)(cid:1)ss).
Societydeemedthediagnosisandtreatmentofindividualswith
5.6. Wesuggestthatcliniciansdeterminethetimingof GD/gender incongruence a priority area for revision and
breastsurgeryfortransgendermalesbasedupon appointed a task force to formulate evidence-based recom-
the physical and mental health status of the in- mendations. The task force followed the approach recom-
mended by the Grading of Recommendations, Assessment,
dividual. There is insufficient evidence to rec-
Development, and Evaluation group, an international group
ommendaspecificagerequirement.(2|(cid:1)sss)
with expertise in the development and implementation of
evidence-based guidelines (1). A detailed description of the
gradingschemehasbeenpublishedelsewhere(2).Thetaskforce
Changes Since the Previous Guideline used the best available research evidence to develop the rec-
ommendations. The task force also used consistent language
Boththecurrentguidelineandtheonepublishedin2009 and graphical descriptions of both the strength of a recom-
contain similar sections. Listed here are the sections mendationandthequalityofevidence.Intermsofthestrength
oftherecommendation,strongrecommendationsusethephrase
containedinthecurrentguidelineandthecorresponding
“werecommend”andthenumber1,andweakrecommenda-
number of recommendations: Introduction, Evaluation
tionsusethephrase“wesuggest”andthenumber2.Cross-filled
of Youth and Adults (5), Treatment of Adolescents (6), circles indicate the quality of the evidence, such that (cid:1)sss
HormonalTherapyforTransgenderAdults(4),Adverse denotes very low–quality evidence; (cid:1)(cid:1)ss, low quality;
Outcomes Prevention and Long-term Care (7), and (cid:1)(cid:1)(cid:1)s,moderatequality;and(cid:1)(cid:1)(cid:1)(cid:1),highquality.Thetask
SurgeryforSexReassignmentandGenderConfirmation forcehasconfidencethatpersonswhoreceivecareaccordingto
the strong recommendations will derive, on average, more
(6). The current introduction updates the diagnostic
benefit than harm. Weak recommendations require more
classification of “gender dysphoria/gender incongru- carefulconsiderationoftheperson’scircumstances,values,and
ence.”Italsoreviewsthedevelopmentof“genderidentity” preferences to determine the best course of action. Linked to
and summarizes its natural development. The section on eachrecommendationisadescriptionoftheevidenceandthe
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values that the task force considered in making the recom- quality of the evidence was low. The second review
mendation. Insome instances, there are remarksin whichthe summarizedtheavailableevidenceregardingtheeffectof
task force offers technical suggestions for testing conditions,
sex steroids on bone health in transgender individuals
dosing, and monitoring. These technical comments reflect the
andidentified13studies.Intransgendermales,therewas
bestavailableevidenceappliedtoatypicalpersonbeingtreated.
nostatisticallysignificantdifferenceinthelumbarspine,
Oftenthisevidencecomesfromtheunsystematicobservations
of the task force and their preferences; therefore, one should femoral neck, or total hip BMD at 12 and 24 months
considertheseremarksassuggestions. compared with baseline values before initiating mascu-
Inthis guideline, the taskforce madeseveral statements to linizing hormone therapy. In transgender females, there
emphasize the importance of shared decision-making, general
was a statistically significant increase in lumbar spine
preventivecaremeasures,andbasicprinciplesofthetreatment
of transgender persons. They labeled these “Ungraded Good BMD at 12 months and 24 months compared with
Practice Statement.” Direct evidence for these statements was baseline values before initiation of feminizing hormone
eitherunavailableornotsystematicallyappraisedandconsid- therapy. There was minimal information on fracture
ered out of the scope of this guideline. The intention of these rates. The quality of evidence was also low.
statementsistodrawattentiontotheseprinciples.
The Endocrine Society maintains a rigorous conflict-of-
interest review process for developing clinical practice guide- Introduction
lines. All task force members must declare any potential
conflicts of interest by completing a conflict-of-interest form. Throughout recorded history (in the absence of an en-
The CGS reviews all conflicts of interest before the Society’s docrine disorder) some men and women have experi-
Councilapprovesthememberstoparticipateonthetaskforce encedconfusionandanguishresultingfromrigid,forced
and periodically during the development of the guideline. All
conformity to sexual dimorphism. In modern history,
others participating in the guideline’s development must also
there have been numerous ongoing biological, psycho-
discloseanyconflictsofinterestinthematterunderstudy,and
most of these participants must be without any conflicts of logical, cultural, political, and sociological debates over
interest.TheCGSandthetaskforcehavereviewedalldisclo- various aspects of gender variance. The 20th century
suresforthisguidelineandresolvedormanagedallidentified markedtheemergenceofasocialawakeningformenand
conflictsofinterest. women with the belief that they are “trapped” in the
Conflicts of interest are defined as remuneration in any
wrong body (3). Magnus Hirschfeld and Harry Benja-
amount from commercial interests; grants; research support;
consulting fees; salary; ownership interests [e.g., stocks and min, among others, pioneered the medical responses to
stockoptions(excludingdiversifiedmutualfunds)];honoraria those who sought relief from and a resolution to their
and other payments for participation in speakers’ bureaus, profound discomfort. Although the term transsexual
advisoryboards,orboardsofdirectors;andallotherfinancial became widely known after Benjamin wrote “The
benefits.CompletedformsareavailablethroughtheEndocrine Transsexual Phenomenon” (4), it was Hirschfeld who
Societyoffice.
coinedtheterm“transsexual”in1923todescribepeople
The Endocrine Society provided the funding for this
guideline; the task force received no funding or remuneration who want to live a life that corresponds with their ex-
fromcommercialorotherentities. periencedgendervstheirdesignatedgender(5).Magnus
Hirschfeld(6)andothers(4,7)havedescribedothertypes
of trans phenomena besides transsexualism. Theseearly
Commissioned Systematic Review
researchers proposed that the gender identity of these
The task force commissioned two systematic reviews to people was located somewhere along a unidimensional
supportthisguideline.Thefirstoneaimedtosummarize continuum. This continuum ranged from all male
the available evidence on the effect of sex steroid use in through“somethinginbetween”toallfemale.Yetsucha
transgender individuals on lipids and cardiovascular classificationdoesnottakeintoaccountthatpeoplemay
outcomes. The review identified 29 eligible studies at have gender identities outside this continuum. For in-
moderate risk of bias. In transgender males (female to stance,someexperiencethemselvesashavingbothamale
male), sex steroid therapy was associated with a statis- and female gender identity, whereas others completely
tically significant increase in serum triglycerides and renounceanygenderclassification(8,9). Therearealso
low-density lipoprotein cholesterol levels. High-density reports of individuals experiencing a continuous and
lipoprotein cholesterol levels decreased significantly rapidinvoluntaryalternationbetweenamaleandfemale
acrossallfollow-uptimeperiods.Intransgenderfemales identity(10)ormenwhodonotexperiencethemselvesas
(male to female), serum triglycerides were significantly menbutdonotwanttoliveaswomen(11,12).Insome
higher without any changes in other parameters. Few countries,(e.g.,Nepal,Bangladesh,andAustralia),these
myocardialinfarction,stroke,venousthromboembolism nonmale or nonfemale genders are officially recognized
(VTE),anddeatheventswerereported.Theseeventswere (13).Specifictreatmentprotocols,however,havenotyet
more frequent in transgender females. However, the been developed for these groups.
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6 Hembreeetal GuidelinesonGender-Dysphoric/Gender-IncongruentPersons JClinEndocrinolMetab,November2017,102(11):1–35
Instead of the term transsexualism, the current studiesacrosscountriesthatusethesamediagnosticand
classification system of the American Psychiatric As- inclusion criteria, medications, assay methods, and re-
sociation uses the term gender dysphoria in its di- sponseassessmenttools(e.g.,theEuropeanNetworkfor
agnosis of persons who are not satisfied with their the Investigation of Gender Incongruence) (17, 18).
designated gender (14). The current version of the Terminologyanditsusevaryandcontinuetoevolve.
World Health Organization’s ICD-10 still uses the term Table1containsthedefinitionsoftermsastheyareused
transsexualism when diagnosing adolescents and throughout this guideline.
adults. However, for the ICD-11, the World Health
Organization has proposed using the term “gender in-
Biological Determinants of Gender
congruence” (15).
Identity Development
Treating personswith GD/gender incongruence(15)
waspreviouslylimitedtorelativelyineffectiveelixirsor One’s self-awareness as male or female changes
creams. However, more effective endocrinology-based gradually during infant life and childhood. This pro-
treatments became possible with the availability of cess of cognitive and affective learning evolves with
testosterone in 1935 and diethylstilbestrol in 1938. interactions with parents, peers, and environment. A
Reports of individuals with GD/gender incongruence fairly accurate timetable exists outlining the steps in
who were treated with hormones and gender-affirming this process (19). Normative psychological literature,
surgery appeared in the pressduring thesecond half of however,doesnotaddressifandwhengenderidentity
the 20th century. The Harry Benjamin International becomes crystallized and what factors contribute to
Gender Dysphoria Association was founded in Sep- the development of a gender identity that is not con-
tember 1979 and is now called the World Professional gruent with the gender of rearing. Results of studies
Association for Transgender Health (WPATH). WPATH from a variety of biomedical disciplines—genetic,
published its first Standards of Care in 1979. These endocrine, and neuroanatomic—support the concept
standardshavesincebeenregularlyupdated,providing that gender identity and/or gender expression (20)
guidance for treating persons with GD/gender in- likely reflect a complex interplay of biological, envi-
congruence (16). ronmental, and cultural factors (21, 22).
Prior to 1975, few peer-reviewed articles were pub- With respect to endocrine considerations, studies
lished concerning endocrine treatment of transgender havefailedtofinddifferencesincirculatinglevelsofsex
persons. Since then, more than two thousand articles steroids between transgender and nontransgender in-
aboutvariousaspectsoftransgendercarehaveappeared. dividuals (23). However, studies in individuals with a
It is the purpose of this guideline to make detailed disorder/difference of sex development (DSD) have in-
recommendations and suggestions, based on existing formed our understanding of the role that hormones
medicalliteratureandclinicalexperience,thatwillenable mayplayingenderidentityoutcome,eventhoughmost
treatingphysicianstomaximizebenefitandminimizerisk persons with GD/gender incongruence do not have
when caring for individuals diagnosed with GD/gender a DSD. For example, although most 46,XX adult in-
incongruence. dividuals with virilizing congenital adrenalhyperplasia
Inthefuture,weneedmorerigorousevaluationsofthe caused by mutations in CYP21A2 reported a female
effectiveness and safety of endocrine and surgical pro- gender identity, the prevalence of GD/gender in-
tocols. Specifically, endocrine treatment protocols for congruence was much greater in this group than in the
GD/gender incongruence should include the careful as- general population without a DSD. This supports the
sessment of the following: (1) the effects of prolonged concept that there is a role for prenatal/postnatal an-
delayofpubertyinadolescentsonbonehealth,gonadal drogensingenderdevelopment(24–26),althoughsome
function, and the brain (including effects on cognitive, studiesindicatethatprenatalandrogensaremorelikely
emotional, social, and sexual development); (2) the ef- to affect gender behavior and sexual orientation rather
fects of treatment in adults on sex hormone levels; (3) than gender identity per se (27, 28).
the requirement for and the effects of progestins and Researchers have made similar observations regarding
other agents used to suppress endogenous sex ste- thepotentialroleofandrogensinthedevelopmentofgender
roidsduringtreatment;and(4)therisksandbenefits identity in other individuals with DSD. For example, a
of gender-affirming hormone treatment in older trans- review of two groups of 46,XY persons, each with an-
gender people. drogen synthesis deficiencies and female raised, reported
To successfully establish and enact these protocols, transgender male (female-to-male) gender role changes in
a commitment of mental health and endocrine investi- 56% to 63% and 39% to 64% of patients, respectively
gatorsisrequiredtocollaborateinlong-term,large-scale (29).Also,in46,XYfemale-raisedindividualswithcloacal
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Table 1. Definitions of Terms Used in This Guideline
Biologicalsex,biologicalmaleorfemale:Thesetermsrefertophysicalaspectsofmalenessandfemaleness.Asthesemaynotbeinline
witheachother(e.g.,apersonwithXYchromosomesmayhavefemale-appearinggenitalia),thetermsbiologicalsexandbiological
maleorfemaleareimpreciseandshouldbeavoided.
Cisgender:Thismeansnottransgender.Analternativewaytodescribeindividualswhoarenottransgenderis“non-transgender
people.”
Gender-affirming(hormone)treatment:See“genderreassignment”
Genderdysphoria:Thisisthedistressanduneaseexperiencedifgenderidentityanddesignatedgenderarenotcompletelycongruent
(seeTable2).In2013,theAmericanPsychiatricAssociationreleasedthefiftheditionoftheDSM-5,whichreplaced“genderidentity
disorder”with“genderdysphoria”andchangedthecriteriafordiagnosis.
Genderexpression:Thisreferstoexternalmanifestationsofgender,expressedthroughone’sname,pronouns,clothing,haircut,
behavior,voice,orbodycharacteristics.Typically,transgenderpeopleseektomaketheirgenderexpressionalignwiththeirgender
identity,ratherthantheirdesignatedgender.
Genderidentity/experiencedgender:Thisreferstoone’sinternal,deeplyheldsenseofgender.Fortransgenderpeople,theirgender
identitydoesnotmatchtheirsexdesignatedatbirth.Mostpeoplehaveagenderidentityofmanorwoman(orboyorgirl).Forsome
people,theirgenderidentitydoesnotfitneatlyintooneofthosetwochoices.Unlikegenderexpression(seebelow),genderidentityis
notvisibletoothers.
Genderidentitydisorder:ThisisthetermusedforGD/genderincongruenceinpreviousversionsofDSM(see“genderdysphoria”).The
ICD-10stillusesthetermfordiagnosingchilddiagnoses,buttheupcomingICD-11hasproposedusing“genderincongruenceof
childhood.”
Genderincongruence:Thisisanumbrellatermusedwhenthegenderidentityand/orgenderexpressiondiffersfromwhatistypically
associatedwiththedesignatedgender.Genderincongruenceisalsotheproposednameofthegenderidentity–relateddiagnosesin
ICD-11.Notallindividualswithgenderincongruencehavegenderdysphoriaorseektreatment.
Gendervariance:See“genderincongruence”
Genderreassignment:Thisreferstothetreatmentprocedureforthosewhowanttoadapttheirbodiestotheexperiencedgenderby
meansofhormonesand/orsurgery.Thisisalsocalledgender-confirmingorgender-affirmingtreatment.
Gender-reassignmentsurgery(gender-confirming/gender-affirmingsurgery):Thesetermsreferonlytothesurgicalpartofgender-
confirming/gender-affirmingtreatment.
Genderrole:Thisreferstobehaviors,attitudes,andpersonalitytraitsthatasociety(inagivencultureandhistoricalperiod)designatesas
masculineorfeminineand/orthatsocietyassociateswithorconsiderstypicalofthesocialroleofmenorwomen.
Sexdesignatedatbirth:Thisreferstosexassignedatbirth,usuallybasedongenitalanatomy.
Sex:Thisreferstoattributesthatcharacterizebiologicalmalenessorfemaleness.Thebestknownattributesincludethesex-determining
genes,thesexchromosomes,theH-Yantigen,thegonads,sexhormones,internalandexternalgenitalia,andsecondarysex
characteristics.
Sexualorientation:Thistermdescribesanindividual’senduringphysicalandemotionalattractiontoanotherperson.Genderidentityand
sexualorientationarenotthesame.Irrespectiveoftheirgenderidentity,transgenderpeoplemaybeattractedtowomen(gynephilic),
attractedtomen(androphilic),bisexual,asexual,orqueer.
Transgender:Thisisanumbrellatermforpeoplewhosegenderidentityand/orgenderexpressiondiffersfromwhatistypicallyassociated
withtheirsexdesignatedatbirth.Notalltransgenderindividualsseektreatment.
Transgendermale(also:transman,female-to-male,transgendermale):Thisreferstoindividualsassignedfemaleatbirthbutwho
identifyandliveasmen.
Transgenderwoman(also:transwoman,male-tofemale,transgenderfemale):Thisreferstoindividualsassignedmaleatbirthbutwho
identifyandliveaswomen.
Transition:Thisreferstotheprocessduringwhichtransgenderpersonschangetheirphysical,social,and/orlegalcharacteristics
consistentwiththeaffirmedgenderidentity.Prepubertalchildrenmaychoosetotransitionsocially.
Transsexual:Thisisanoldertermthatoriginatedinthemedicalandpsychologicalcommunitiestorefertoindividualswhohave
permanentlytransitionedthroughmedicalinterventionsordesiredtodoso.
exstrophy and penile agenesis, the occurrence of trans- specific genes associated with GD/gender incongruence,
gender male changes was significantly more prevalent such studies have been inconsistent and without strong
thaninthegeneralpopulation(30,31).However,thefact statistical significance (34–38).
that a high percentage of individuals with the same Studies focusing on brain structure suggest that the
conditions did not change gender suggests that cultural brain phenotypes of people with GD/gender incongru-
factors may play a role as well. ence differ in various ways from control males and fe-
With respect to genetics and gender identity, several males, but that there is not a complete sex reversal in
studies have suggested heritability of GD/gender in- brain structures (39).
congruence (32, 33). In particular, a study by Heylens In summary, although there is much that is still
et al. (33) demonstrated a 39.1% concordance rate for unknown with respect to gender identity and its ex-
genderidentitydisorder(basedontheDSM-IVcriteria)in pression, compelling studies support the concept that
23 monozygotic twin pairs but no concordance in 21 biologic factors, in addition to environmental fac-
same-sex dizygotic or seven opposite-sex twin pairs. tors, contribute to this fundamental aspect of human
Althoughnumerousinvestigatorshavesoughttoidentify development.
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8 Hembreeetal GuidelinesonGender-Dysphoric/Gender-IncongruentPersons JClinEndocrinolMetab,November2017,102(11):1–35
Natural History of Children With this improves their quality of life. Although the focus of
GD/Gender Incongruence this guideline is gender-affirming hormone therapy, col-
laborationwithappropriateprofessionalsresponsiblefor
With current knowledge, we cannot predict the psy-
eachaspectoftreatmentmaximizesasuccessfuloutcome.
chosexual outcome for any specific child. Prospective
follow-up studies show that childhood GD/gender in- Diagnostic assessment and mental health care
congruencedoesnotinvariablypersistintoadolescence GD/gender incongruence may be accompanied with
and adulthood (so-called “desisters”). Combining all psychological or psychiatric problems (43–51). It is
outcome studies to date, the GD/gender incongruence therefore necessary that clinicians who prescribe hor-
ofaminorityofprepubertalchildrenappearstopersist mones and are involved in diagnosis and psychosocial
in adolescence (20, 40). In adolescence, a significant assessmentmeetthefollowingcriteria:(1)arecompetent
number of these desisters identify as homosexual or in using the DSM and/or the ICD for diagnostic pur-
bisexual.Itmaybethatchildrenwhoonlyshowedsome poses,(2)areabletodiagnoseGD/genderincongruence
gender nonconforming characteristics have been in- and make a distinction between GD/gender incongru-
cluded in the follow-up studies, because the DSM-IV enceandconditionsthathavesimilarfeatures(e.g.,body
text revision criteria for a diagnosis were rather broad. dysmorphic disorder), (3) are trained in diagnosing
However, the persistence of GD/gender incongruence psychiatric conditions, (4) undertake or refer for ap-
intoadolescenceismorelikelyifithadbeenextremein propriate treatment, (5) are able to do a psychosocial
childhood (41, 42). With the newer, stricter criteria of assessment of the patient’s understanding, mental
the DSM-5 (Table 2), persistence rates may well be health, and social conditions that can impact gender-
different in future studies. affirming hormone therapy, and (6) regularly attend
relevant professional meetings.
Because of the psychological vulnerability of many
1.0 Evaluation of Youth and Adults
individualswithGD/genderincongruence,itisimportant
Gender-affirming treatment is a multidisciplinary effort. that mental health care is available before, during, and
Afterevaluation,education,anddiagnosis,treatmentmay sometimes also after transitioning. For children and
include mental health care, hormone therapy, and/or adolescents, an MHP who has training/experience in
surgical therapy. Together with an MHP, hormone- childandadolescentgenderdevelopment(aswellaschild
prescribing clinicians should examine the psychosocial and adolescent psychopathology) should make the di-
impactofthepotentialchangesonpeople’slives,including agnosis, because assessing GD/gender incongruence in
mental health, friends, family, jobs, and their role in so- children and adolescents is often extremely complex.
ciety. Transgender individuals should be encouraged to Duringassessment,theclinicianobtainsinformationfrom
experiencelivinginthenewgenderroleandassesswhether theindividualseekinggender-affirmingtreatment.Inthecase
Table 2. DSM-5 Criteria for Gender Dysphoria in Adolescents and Adults
A.Amarkedincongruencebetweenone’sexperienced/expressedgenderandnatalgenderofatleast6moinduration,asmanifestedby
atleasttwoofthefollowing:
1.Amarkedincongruencebetweenone’sexperienced/expressedgenderandprimaryand/orsecondarysexcharacteristics(orin
youngadolescents,theanticipatedsecondarysexcharacteristics)
2.Astrongdesiretoberidofone’sprimaryand/orsecondarysexcharacteristicsbecauseofamarkedincongruencewithone’s
experienced/expressedgender(orinyoungadolescents,adesiretopreventthedevelopmentoftheanticipatedsecondarysex
characteristics)
3.Astrongdesirefortheprimaryand/orsecondarysexcharacteristicsoftheothergender
4.Astrongdesiretobeoftheothergender(orsomealternativegenderdifferentfromone’sdesignatedgender)
5.Astrongdesiretobetreatedastheothergender(orsomealternativegenderdifferentfromone’sdesignatedgender)
6.Astrongconvictionthatonehasthetypicalfeelingsandreactionsoftheothergender(orsomealternativegenderdifferentfrom
one’sdesignatedgender)
B.Theconditionisassociatedwithclinicallysignificantdistressorimpairmentinsocial,occupational,orotherimportantareasof
functioning.
Specifyif:
1.Theconditionexistswithadisorderofsexdevelopment.
2.Theconditionisposttransitional,inthattheindividualhastransitionedtofull-timelivinginthedesiredgender(withorwithout
legalizationofgenderchange)andhasundergone(orispreparingtohave)atleastonesex-relatedmedicalprocedureortreatment
regimen—namely,regularsexhormonetreatmentorgenderreassignmentsurgeryconfirmingthedesiredgender(e.g.,
penectomy,vaginoplastyinnatalmales;mastectomyorphalloplastyinnatalfemales).
Reference:AmericanPsychiatricAssociation(14).
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doi:10.1210/jc.2017-01658 https://academic.oup.com/jcem 9
of adolescents, the clinician also obtains informa- startgender-affirminghormonetreatmenttomakesocial
tion from the parents or guardians regarding various transitioning easier, but individuals increasingly start
aspects of the child’s general and psychosexual devel- social transitioning long before they receive medically
opment and current functioning. On the basis of this supervised, gender-affirming hormone treatment.
information, the clinician:
· Criteria
decides whether the individual fulfills criteria for
Adolescents and adults seeking gender-affirming
treatment (see Tables 2 and 3) for GD/gender in-
hormone treatment and surgery should satisfy certain
congruence (DSM-5) or transsexualism (DSM-5
criteria before proceeding (16). Criteria for gender-
and/or ICD-10);
· affirming hormone therapy for adults are in Table 4,
informs the individual about the possibilities and
and criteria for gender-affirming hormone therapy for
limitationsofvariouskindsoftreatment(hormonal/
adolescents are in Table 5. Follow-up studies in adults
surgical and nonhormonal), and if medical treat-
meeting these criteria indicate a high satisfaction rate
ment is desired, provides correct information to
withtreatment(59).However,thequalityofevidenceis
prevent unrealistically high expectations;
· usuallylow.Afewfollow-upstudiesonadolescentswho
assesseswhethermedicalinterventionsmayresultin
fulfilled these criteria also indicated good treatment
unfavorable psychological and social outcomes. results (60–63).
Incasesinwhichseverepsychopathology,circumstances,
orbothseriouslyinterferewiththediagnosticworkormake
Recommendations for Those Involved
satisfactory treatment unlikely, clinicians should assist the
in the Gender-Affirming Hormone
adolescent in managing these other issues. Literature on
Treatment of Individuals With
postoperative regret suggests that besides poor quality of
GD/Gender Incongruence
surgery,severepsychiatriccomorbidityandlackofsupport
mayinterferewithpositiveoutcomes(52–56). 1.1. WeadvisethatonlytrainedMHPswhomeetthe
For adolescents, the diagnostic procedure usually following criteria should diagnose GD/gender
includes a complete psychodiagnostic assessment (57) incongruence in adults: (1) competence in using
and an assessment of the decision-making capability of theDSMand/ortheICDfordiagnosticpurposes,
theyouth.Anevaluationtoassessthefamily’sabilityto (2) the ability to diagnose GD/gender incongru-
endure stress, give support, and deal with the complex- enceandmakeadistinctionbetweenGD/gender
ities of the adolescent’s situation should be part of the incongruence and conditions that have similar
diagnostic phase (58). features (e.g., body dysmorphic disorder), (3)
trainingindiagnosingpsychiatricconditions,(4)
Social transitioning the ability to undertake or refer for appropriate
A change in gender expression and role (which may treatment, (5) the ability to psychosocially assess
involvelivingparttimeorfulltimeinanothergenderrole the person’s understanding, mental health, and
thatisconsistentwithone’sgenderidentity)maytestthe socialconditionsthatcanimpactgender-affirming
person’sresolve,thecapacitytofunctionintheaffirmed hormone therapy, and (6) a practice of regularly
gender, and the adequacy of social, economic, and psy- attending relevant professional meetings. (Un-
chologicalsupports.Itassistsboththeindividualandthe graded Good Practice Statement)
clinician in their judgments about how to proceed (16). 1.2. We advise that only MHPs who meet the fol-
During social transitioning, the person’s feelings about lowing criteria should diagnose GD/gender in-
the social transformation (including coping with the re- congruence in children and adolescents: (1)
sponses of others) is a major focus of the counseling. training in child and adolescent developmental
The optimal timing for social transitioning may differ psychology and psychopathology, (2) compe-
between individuals. Sometimes people wait until they tenceinusingtheDSMand/orICDfordiagnostic
Table 3. ICD-10 Criteria for Transsexualism
Transsexualism(F64.0)hasthreecriteria:
1.Thedesiretoliveandbeacceptedasamemberoftheoppositesex,usuallyaccompaniedbythewishtomakehisorherbodyas
congruentaspossiblewiththepreferredsexthroughsurgeryandhormonetreatments.
2.Thetranssexualidentityhasbeenpresentpersistentlyforatleast2y.
3.Thedisorderisnotasymptomofanothermentaldisorderoragenetic,DSD,orchromosomalabnormality.
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10 Hembreeetal GuidelinesonGender-Dysphoric/Gender-IncongruentPersons JClinEndocrinolMetab,November2017,102(11):1–35
Table 4. Criteria for Gender-Affirming Hormone Therapy for Adults
1.Persistent,well-documentedgenderdysphoria/genderincongruence
2.Thecapacitytomakeafullyinformeddecisionandtoconsentfortreatment
3.Theageofmajorityinagivencountry(ifyounger,followthecriteriaforadolescents)
4.Mentalhealthconcerns,ifpresent,mustbereasonablywellcontrolled
ReproducedfromWorldProfessionalAssociationforTransgenderHealth(16).
purposes, (3) the ability to make a distinction Evidence
betweenGD/genderincongruenceandconditions Individuals with gender identity issues may have
thathavesimilarfeatures(e.g., bodydysmorphic psychologicalorpsychiatricproblems(43–48,50,51,64,
disorder), (4) training in diagnosing psychiatric 65). It is therefore necessary that clinicians making the
conditions,(5)theabilitytoundertakeorreferfor diagnosis are able to make a distinction between GD/
appropriate treatment, (6) the ability to psycho- gender incongruence and conditions that have similar
socially assess the person’s understanding and features.Examplesofconditionswithsimilarfeaturesare
socialconditionsthatcanimpactgender-affirming body dysmorphic disorder, body identity integrity dis-
hormone therapy, (7) a practice of regularly at- order(aconditioninwhichindividualshaveasensethat
tending relevant professional meetings, and (8) theiranatomicalconfigurationasanable-bodiedperson
knowledge of the criteria for puberty blocking is somehow wrong or inappropriate) (66), or certain
and gender-affirming hormone treatment in ad- forms of eunuchism (in which a person is preoccupied
olescents. (Ungraded Good Practice Statement) with or engages in castration and/or penectomy for
Table 5. Criteria for Gender-Affirming Hormone Therapy for Adolescents
AdolescentsareeligibleforGnRHagonisttreatmentif:
·1.AqualifiedMHPhasconfirmedthat:
theadolescenthasdemonstratedalong-lastingandintensepatternofgendernonconformityorgenderdysphoria(whether
·suppressedorexpressed),
·genderdysphoriaworsenedwiththeonsetofpuberty,
anycoexistingpsychological,medical,orsocialproblemsthatcouldinterferewithtreatment(e.g.,thatmaycompromisetreatment
·adherence)havebeenaddressed,suchthattheadolescent’ssituationandfunctioningarestableenoughtostarttreatment,
theadolescenthassufficientmentalcapacitytogiveinformedconsenttothis(reversible)treatment,
·2.Andtheadolescent:
hasbeeninformedoftheeffectsandsideeffectsoftreatment(includingpotentiallossoffertilityiftheindividualsubsequently
·continueswithsexhormonetreatment)andoptionstopreservefertility,
hasgiveninformedconsentand(particularlywhentheadolescenthasnotreachedtheageoflegalmedicalconsent,dependingon
applicablelegislation)theparentsorothercaretakersorguardianshaveconsentedtothetreatmentandareinvolvedinsupporting
theadolescentthroughoutthetreatmentprocess,
·3.Andapediatricendocrinologistorotherclinicianexperiencedinpubertalassessment
·agreeswiththeindicationforGnRHagonisttreatment,
·hasconfirmedthatpubertyhasstartedintheadolescent(Tannerstage$G2/B2),
hasconfirmedthattherearenomedicalcontraindicationstoGnRHagonisttreatment.
Adolescentsareeligibleforsubsequentsexhormonetreatmentif:
·1.AqualifiedMHPhasconfirmed:
·thepersistenceofgenderdysphoria,
anycoexistingpsychological,medical,orsocialproblemsthatcouldinterferewithtreatment(e.g.,thatmaycompromisetreatment
adherence)havebeenaddressed,suchthattheadolescent’ssituationandfunctioningarestableenoughtostartsexhormone
·treatment,
theadolescenthassufficientmentalcapacity(whichmostadolescentshavebyage16years)toestimatetheconsequencesofthis
(partly)irreversibletreatment,weighthebenefitsandrisks,andgiveinformedconsenttothis(partly)irreversibletreatment,
·2.Andtheadolescent:
hasbeeninformedofthe(irreversible)effectsandsideeffectsoftreatment(includingpotentiallossoffertilityandoptionstopreserve
·fertility),
hasgiveninformedconsentand(particularlywhentheadolescenthasnotreachedtheageoflegalmedicalconsent,dependingon
applicablelegislation)theparentsorothercaretakersorguardianshaveconsentedtothetreatmentandareinvolvedinsupporting
theadolescentthroughoutthetreatmentprocess,
·3.Andapediatricendocrinologistorotherclinicianexperiencedinpubertalinduction:
·agreeswiththeindicationforsexhormonetreatment,
hasconfirmedthattherearenomedicalcontraindicationstosexhormonetreatment.
ReproducedfromWorldProfessionalAssociationforTransgenderHealth(16).
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