Jennifer M Demma MSN APRNCNM Disclosures No disclosures or conflicts of interest Objectives Understand informed consent and harm reduction principles as applied to provision of genderaffirming hormone care ID: 934339
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Slide1
Providing Gender-Affirming Hormone Care for Transgender and Gender Non-Conforming Individuals
Jennifer M.
Demma
, MSN, APRN-CNM
Slide2Disclosures
No disclosures or conflicts of interest
Slide3Objectives
Understand informed consent and harm reduction principles as applied to provision of gender-affirming hormone care.
Identify best clinical practices for providing gender-affirming hormone care to transgender and gender non-conforming individuals.
Understand and be prepared to offer basic hormone therapy protocols for gender affirmation, including knowledge of common side effects and monitoring of medical transition
Slide4Jennifer M.
Demma
, MSN, APRN-CNM
Pronouns: She/Her/Hers
CNM since 2000
Clinical Practice Director
Family Tree Clinic, St Paul, MN
jdemma@familytreeclinic.org
Slide5Gender Dysphoria
Feeling of distress due to one’s internal sense or perception of their own gender not being congruent with the sex they were assigned at birth, or their natal sex.
Result of interactions of biological, environmental, psychosocial, and cultural factors.
Not all transgender people experience gender
dysphoria
but those who do often feel isolated.
Contributes to increases in anxiety and depression.
Diagnosis classified in the DSM-5
Increasing evidence that gender
dysphoria
is best treated by a multi-disciplinary approach which includes gender-affirming hormone therapy.
(Hembree et al., 2009; Atkinson & Russell, 2015; Schmidt & Levine, 2015)
Slide6Benefits of Gender Affirming Care
Gender affirmation is essential to health and wellbeing for transgender and gender nonconforming people and communities.
Decreased mental health risks
Decreased suicide
Improved quality of life
(Bauer et al., 2015;
Reisner
, Radix,
& Deutsch, 2016)
Slide7Gender Affirming Care
Individualized and can change with time and is ongoing
No one way to affirm gender
Not necessarily a linear process
Gender expression is not the same as gender identity and may or may not change as a part of gender affirmation
May involve hormone therapy or not
May involve surgery or not
May involve name change and/or gender marker change or not
Social; psychological; medical; and legal
Slide8Why Should We Provide Hormones?
Improvements in gender dysphoria, psychological functioning, comorbidities, sexual functioning and overall quality of life.
More providers = improved access to health care.
Decreases in health disparities
Build trust and strengthen the clinician-patient relationship.
Within our scope of practice, not an endocrine specialty
Majority of endocrinologists also report little to no experience with transgender patients.
Only ~16% report currently caring for > 5 transgender patients.
Over 2/3 received no training in medical school or fellowship.
(Irwig, 2016; Murad et al., 2010)
Slide9Goals of Gender-Affirming Hormone Therapy
Broad overall goal:
Help people live authentically in congruence with how they view themselves internally and their values.
Medically:
Suppress the secondary sex characteristics of the gender the person was assigned at birth by blocking endogenous sex hormones.
Induce the development of secondary sex characteristics of the gender with which the person identifies by administering hormones consistent with that sex.
(Hembree et al., 2009)
Slide10Hormone Therapy Guidelines
Lack of consensus and limited longitudinal studies.
Review the published guidelines:
UCSF, Center of Excellence for Transgender Care
–
Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Non-Binary People
Fenway Health
–
The Medical Care of Transgender Persons
Callen-Lorde
– Protocols for the Provision of Hormone TherapyEndocrine Treatment of Gender-Dysphoric
/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline, 2017
WPATH
–
Standards of Care, Version 7
It is ok to simply pick one and follow an established set of guidelines – it is more harmful to withhold hormone therapy for gender affirmation.
WPATH has listserv for questions – join WPATH and follow listserv.
Talk with other providers.
Slide11Informed Consent
Communicating benefits, risks, side effects, alternatives, limitations of knowledge, and risk of no treatment.
Respecting patient autonomy and right of self-determination.
Person as the expert in their well-being.
Partnership with provider-patient
Removing “gatekeeping”
Does not mean lack of clinical assessment & does not mean that hormones are always prescribed.
Clinician assesses readiness to initiate hormone therapy and documents that patient has capacity to make informed consent.
Minimal risk of regret and NO malpractice suits found in study of clinics using informed consent model.
(Center of Excellence for Transgender Health, 2016; Cavanaugh, Hopwood, & Lambert, 2016; Deutsch, 2012; WPATH, 2012)
Slide12Initial Assessment and Readiness
Subjective
Describe to me how you came to identify as transgender/gender non-conforming/
agender
/non-binary
……
.
What are your goals for hormone therapy?
What are the changes you are most hoping to see when you start hormones?
What are some of the barriers you anticipate with transition?
Who in your life is supportive of you? Who are you out to?
Are you in a safe place to transition?Are you sexually active?Do you see yourself as a parent in the future?
Slide13Initial Assessment and Readiness
Review current medications,
PMHx
, and
FHx
Review of Informed Consent
Counseling
Expectations of hormone therapy
Timelines of physical changes
Minimizing modifiable risk factors
Smoking cessation, alcohol and drug use, safer sex practices
Set timeline for follow up appointments – at 3, 6, 9, and 12 months in the first year then every 6-12 months and PRN.
Slide14Exams and Screenings
Physical exam
Vital signs
Heart, lungs, thyroid, abdomen, offer breast/chest exam if indicated
Genital exam
Not required
Recommend per screening guidelines
Screenings
–
recommend based on sexual behaviors and guidelines
STI’s
PapProstateVaccinationsHPVFluContraception if indicated
Slide15Initial Labs
Feminizing:
Fasting lipid panel
CMP
Diabetes screen if indicated/risk factors
Consider baseline prolactin
Masculinizing:
Fasting lipid panel
CBC
LFTs
Diabetes screen if indicated/risk factorsUPT if at risk of pregnancy Baseline testosterone if PCOS
(Cavanaugh, Hopwood, Gonzalez, & Thompson, 2015)
Slide16Follow-up Labs
Feminizing
-- Example of recommendation from Fenway
Potassium and BUN/
Cre
at 2-8 weeks after starting or changing dose
Lipids, diabetes screen, electrolytes, BUN/
Cre
at 6
mos
then every 6-12
mosProlactin yearlyTestosterone at 6 months after stable dose or inadequate feminizing -- goal is in pre-menopausal cis-female lab rangeEstradiol -- if on injectables; target middle of premenopausal cis-female lab range
NOTE: UCSF, Endocrine Society,
Callen
Lorde
, etc. all vary in guidelines and recommendations – lack of consensus.
(Cavanaugh, Hopwood, Gonzalez, & Thompson, 2015)
Slide17Source: UCSF Center for Excellence in Transgender Health, 2016
Table 2. Laboratory monitoring for feminizing hormone therapy
Test
Comments
Baseline
3 months*
6 months*
12 months*
Yearly
PRN
* In first year of therapy only
** Used to
calculate bioavailable testosterone
; monitoring bioavailable testosterone is optional and may be helpful in complex cases (see text)
BUN/Cr/K+
Only if spiro used
X
X
X
X
X
X
Lipids
No evidence to support monitoring at any time; use clinician discretion
Based on USPSTF guidelines
X
A1c or glucose
No evidence to support monitoring at any time; use clinician discretion
Based on USPSTF guidelines
Estradiol
X
X
X
Total Testosterone
X
X
X
X
Sex Hormone Binding Globulin (SHBG)**
X
X
X
X
Albumin**
X
X
X
X
Prolactin
Only if symptoms of prolactinoma
X
Slide18Follow-up Labs
Masculinizing
– Example of recommendation from Fenway
CBC, lipids, LFTs at 6 months and every 6-12 months
Other labs based on risks i.e., diabetes screening
Serum total testosterone if inadequate masculinizing response (i.e., no cessation of menses at 6 months) or if checking for
supraphysiologic
levels; try to get mid-injection interval; targeting mid range of
cis
-male lab levels
NOTE: UCSF, Endocrine Society,
Callen Lorde
, etc. all vary in guidelines and recommendations – lack of consensus.
(Cavanaugh, Hopwood, Gonzalez, & Thompson, 2015)
Slide19Table 2. Titration and monitoring of masculinizing hormone therapy
Therapy
Comments
Baseline
3 months*
6 months*
12 months*
Yearly
PRN
* In first year of therapy only;
** is optional and may be helpful in complex cases (see text)
Used to calculate bioavailable testosterone; monitoring bioavailable testosterone
Lipids
No evidence to support lipid monitoring at any time; use clinician discretion
Based on USPSTF guidelines
X
A1c or fasting glucose
No evidence to support lipid monitoring at any time; use clinician discretion
Based on USPSTF guidelines
X
Estradiol
X
Total Testosterone
X
X
X
X
Sex Hormone Binding Globulin (SHBG)**
X
X
X
X
Albumin**
X
X
X
X
Hemoglobin & Hematocrit
X
X
X
X
X
X
Source: UCSF Center for Excellence in Transgender Health, 2016
Slide20Hormone Medications
Masculinizing
Testosterone
Transdermal
Gel
Pump
Creams
Patch
Injections
IM
or
SQEvery 10 week injection
Implants
Feminizing
Anti-androgen
Spironolactone
Finasteride
Others
Estrogen
Transdermal patch
Injections IM
Tablets
Slide21Risks of Feminizing Hormones
Likely increased risk:
VTE (higher risk with oral estradiol than transdermal estradiol; difficult to determine given use of ethinyl estradiol and conjugated estrogens in the past
–
which are not recommended) risk increased with risk factors:
>40, smoking
highly sedentary
Underlying
thrombophilic
disorders
Gallstones
Elevated liver enzymesHypertriglyceridemiaCardiovascular disease (other risk factors contribute and a
ge
>
50
)
(WPATH, 2012)
Slide22Risks of Feminizing Hormones
Possible increased risk
Hypertension
Hyperprolactinemia
or
prolactinoma
Type 2 diabetes
Inconclusive or no increased risk
Breast cancer
Pre-existing lipid d/o may benefit from transdermal versus oral estradiol
(WPATH, 2012)
Slide23Risks of Masculinizing Hormones
Likely increased risk:
Polycythemia
Acne
Androgenic alopecia
Sleep apnea
(WPATH, 2012)
Slide24Risks of Masculinizing Hormones
Possible increased risk:
Elevated liver enzymes
Hyperlipidemia (transdermal may be more lipid neutral)
Destabilization of psychiatric disorders associated with higher doses or
supraphysiologic
blood levels, bipolar, schizoaffective or other disorders that may include manic or psychotic symptoms
(WPATH, 2012)
Slide25Risks ofMasculinizing Hormones
Inconclusive or no increased risk
Cardiovascular disease (mostly with risk factors)
Hypertension (not from hormone therapy alone; risk factors)
Type 2 diabetes
Loss of bone density
Breast/cervical/ovarian/uterine CA
(WPATH, 2012)
Slide26Absolute Contraindications
Estrogen
Previous VTE related to underlying
hypercoagulable
condition; history of estrogen sensitive neoplasm; end stage chronic liver disease
Other conditions, i.e., HTN – are not necessarily absolute contraindications – goal is reasonably well controlled prior to starting hormone therapy; may need consultations before starting meds but may be able to start spironolactone initially then add in estradiol once BP well controlled
Testosterone
Pregnancy; unstable coronary artery disease; untreated polycythemia with a
Hct
55% or higher; consult with oncologist with history of breast or other estrogen dependent CAs (due to aromatization of testosterone)
(WPATH, 2012)
Slide27Effects & Onset of Feminizing Hormones
Effect
Expected Onset
Time
to Max Effect
Body
fat redistribution
3-6
months
2-5 years
Decreased muscle mass
3-6 months
1-2 years
Skin softening
3-6 months
Decreased
libido
1-3
months
1-2 years
Decreased
spontaneous erections
1-3 months
3-6 months
*Breast growth
3-6 months
2-3 years
Testicular atrophy
3-6 months
2-3
years
*Decreased sperm production
Variable
Variable
Thinning
body and facial hair
6-12 months
> 3 years
* Permanent effects
(WPATH, 2012)
Slide28Feminizing Hormone Therapy
All considered off label.
Multi-medication therapy:
Androgen blocking
Estradiol
Progestagen
???
Primary class of estrogen used = 17-beta estradiol.
Bioidentical
hormone
Delivered oral, injectable, transdermal patch
Ethinyl estradiol and conjugated equine estrogens NOT recommended due to increased VTE risk and inability to accurately measure serum levels.
(Center of Excellence for Transgender Health, 2016)
Slide29Feminizing Hormone Therapy
Androgen blocking
Spironolactone
–
first line
Initial 50mg PO BID OR 100mg PO QD
Can increase to 150mg or 200mg daily to achieve testosterone suppression
Max dose 400mg QD (200mg PO BID) (UCSF)
Finasteride
–
second line or unable to use spironolactone or to promote hair regrowth
5mg PO dailyTitrate dosing based on suppression of testosterone – goal in premenopausal cis-female range – If binary goals
(Center of Excellence for Transgender Health, 2016)
Slide30Feminizing Hormone Therapy
Estradiol
Oral/sublingual: 2-8mg in divided doses daily
Initial 2-4mg / day (2mg QD or BID)
Increase to 6-8mg / day
If up to 8mg / day should consider changing to IM; risk of VTE higher with 8mg PO than with injectable.
Intramuscular injection:
Estradiol Valerate 20-40mg q 2 weeks OR Estradiol Cypionate 2-5mg IM q 2 weeks (UCSF)
Clinically can often see supratherapeutic levels and may need lower doses; i.e., Endocrine Society Guidelines recommend 2mg IM weekly or 5mg IM q 2 weeks starting dose
Transdermal - Estradiol patch 0.1mg/24 hours 1 patch change every 3-4 days – 2 patches total per week (max 3-4 patches at a time/6-8 patches per week)
Titrate dosing based on desired effects and interpretation of hormone levels on lab results.
Not yet evidence based.
If measuring estrogen want it to be in the range of a pre-menopausal cisgender female.
(Center of Excellence for Transgender Health, 2016)
Slide31Feminizing Hormone Therapy
Progestagens
Micronized Progesterone 100mg-200mg QHS or Medroxyprogesterone acetate 5mg-10mg QD
Controversial and no agreement on usefulness vs. safety
No well designed studies for the role of
progestagens
in treatment of trans women.
Anecdotal evidence shows addition of
progestagen
can improve breast and areolar development, mood, and libido.
Concerns from WHI
– increased risk of CVD and
BrCA
HOWEVER
…
trans women are typically younger, have lower risk of
BrCA
, different estrogen used in WHI
Goals for trans women are improvements in mental health and quality of life, not disease prevention.
“Risks in trans women a likely minimal or absent.”
(Center of Excellence for Transgender Health, 2016)
Slide32MaintenanceFeminizing Hormones
At follow up visits:
Review changes in Med
hx
; Social
hx
; Psychosocial Needs
Assess for medication response:
Skin changes; Body shape changes
Breast growth
Facial and body hair growth
Changes in frequency of erections, libido, testicle sizeMoodAssess for adverse side effects
–
headaches, nipple discharge, vision changes, pain/swelling in legs, chest or abdominal pain
Verify dosing and schedule of medication.
Physical exam
–
as indicated
Does not occur in a vacuum
…
Remember
:
Sexual partners, need for STI screening?
Prostate screenings if age appropriate.
Slide33Effects & Onset ofMasculinizing Hormones
Effect
Expected
Onset
Time to Max Effect
Skin
oiliness/acne
1-6 months
1-2 years
*Facial/body
hair growth
3-6 months
3-5 years
Increased
muscle mass
3-6 months
2-5 years
Body fat
redistribution
3-6 months
2-5 years
Cessation of menses
2-6 months
*Clitoral enlargement
3-6 months
1-2 years
Vaginal atrophy
3-6 months
1-2 years
*Voice
deepening
3-12 months
1-2 years
*Male pattern baldness
>12 months
Variable
* Permanent effects
(WPATH, 2012)
Slide34Masculinizing Hormone Therapy
All considered off label.
All testosterone preparations in the U.S. are considered bioidentical.
Testosterone cypionate or enanthate
Initial dose 20-50mg q week SQ or IM
Increase to max 100mg q week SQ or IM (can increase in intervals, i.e., change from 40mg/week to 50mg/week or 60mg/week x 3 months and re-evaluate)
Testosterone topical gel 1%
Initial dose 12.5-50mg q am
Increase to max 100mg q am
Slower onset of results and lower peaks than SQ/IM
Titrate dosing based on desired side effects and interpretation of hormone levels on lab results.
Not yet evidence based.
Use reference ranges for cisgender men.
Goal is for mid-range at mid-injection cycle (lab dependent).
(Center of Excellence for Transgender Health, 2016)
Slide35MaintenanceMasculinizing Hormones
At follow up visits:
Review changes in Med
hx
, Social
hx
; Psychosocial Needs
Assess response to medication:
Facial and body hair growth
Deepening of voice
Cessation of menses
Skin changes, acne, body odorClitoral growth/”bottom growth”Mood
Body shape changes
Verify dosing and schedule of medication.
Physical exam
–
as indicated
Does not occur in a vacuum
…
Remember:
Sexual partners, need for STI screening or contraception?
Continue to discuss recommendations for cervical cancer screening
Slide36Example Visit Schedule
Initial Visit: full histories, assess need for additional care or conditions needing care before hormone start or any absolute contraindications or medical interactions, informed consent & hormone education, baseline labs
Follow-up visit in 1-2 weeks: physical exam (chest/breast and genital exams not required), lab review, hormone start if no absolute contraindications
Follow-up visits Q 3 months until stable dose then every 6-12 months
Slide37Case Examples
Slide38Questions/Discussion
Slide39References
Atkinson, S.R., & Russell, D. (2015). Gender dysphoria.
Australian Family Physician, 44
(11), 792-796. Retrieved from http://
www.racgp.org.au
/
afp
/2015/
november
/gender-dysphoria/
Bauer, G.R.,
Scheim, A.I., Pyne, J., Travers, R., & Hammond, R. (2015). Intervenable factors associated with suicide risk in transgender persons: A respondent driven sampling study in Ontario, Canada. BMC Public Health, 15. doi: 10.1186/s12889-015-1867-2Boudreau, D. & Mukerjee, R. (2019). Contraception care for transmasculine individuals on testosterone therapy. Journal of Midwifery & Women’s Health, 64(4).Callen-Lorde Community Health Center. (2014). Protocols for the provision of hormone therapy. callen-lorde.org/transhealth/Cavanaugh, T., Hopwood, R. Gonzalez, A, & Thompson, J. (2015). The medical care of transgender persons. Boston, MA: Fenway Health.
Cavanaugh, T. Hopwood, R., & Lambert, C. (2016) Informed consent in the medical care of transgender and gender-nonconforming patients. AMA Journal of Ethics, 18(11): 1147-1155.
Center of Excellence for Transgender Health, Department of Family and Community Medicine, University of California San Francisco. (2016). Guidelines for the primary and gender-affirming care of transgender and gender nonbinary people (2nd ed).
www.transhealth.ucsf.edu/
guidelines.
Deutsch, MB. (2012). Use of the informed consent model in the provision of cross-sex hormone therapy: A survey of the practices of selected clinics. International Journal of Transgenderism, 3: 140-146.
Slide40References
Ellis, A.,
Wojnar
, D. M., &
Pettinato
, M. (2014). Conception, pregnancy, and birth experiences of male and gender variant gestational parents: It’s how we could have a family. Journal of Midwifery & Women’s Health, 60 (1).
Ellis, S. &
Dalke
, L. (2019). Midwifery care of transfeminine individuals. Journal of Midwifery & Women’s Health. 64: 298-311.
Hembree
, W.C., Cohen-
Kettenis, P., Gooren, L., Hannema, S.E., Meyer, W.J., Hassan Murad M., Rosenthal, S.M., Safer, J.D., Tangpricha, V., & T’Sjoen, G.G. (2017). Endocrine treatment of gender-dysphoric/gender-incongruent persons: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism, 102(11), 3869-3903.
Irwig
, M. (2016). Transgender care by endocrinologists in the United States.
Endocrine Practice, 22
(7), 832-836
James, S. E., Herman, J. L., Rankin, S.,
Keisling
, M.,
Mottet
, L., & Anafi, M. (2016). Executive summary of the report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality
Murad, M.H.,
Elamin
, M.B., Garcia, M.Z., Mullan, R.J., Murad, A., Erwin, P.J.,
Montori
, V.M. (2010). Hormonal therapy and sex reassignment: a systematic review and meta-analysis of quality of life and psychosocial outcomes.
Clinical Endocrinology, 72
, 214-231.
Reisner, S.L., Radix, A., & Deutsch, M.B. (2016). Integrated and gender-affirming transgender clinical care and research. Journal of Acquired Immune Deficiency Syndrome. 72(suppl 3):S235-S242.
doi
: 10-1097/QAI.0000000000001088
Schmidt, L., & Levine, R. (2015). Psychological outcomes and reproductive issues among gender dysphoric individual.
Endocrinology Metabolism Clinics of North America, 44
, 773-785
World Professional Association for Transgender Health (WPATH). (2012). Standards of care for the health of transsexual, transgender, and gender-nonconforming people, version 7.
Wylie, C. H., Cohen-
Kettenis
, P. T.,
Gooren
, L.,
Hannema
, S. E., Meyer, W. J., Murad, M. H., Rosenthal, S. M., Safer, J. D.,
Tangpricha
, V., &
T’Sjoen
, G. G. (2017). Endocrine treatment of gender-dysphoric/gender-incongruent persons: An endocrine society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism, 102(11): 3869-3903.