Basics of Hormone Therapy for Transgender Patients Julie K

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Basics of Hormone Therapy for Transgender Patients Julie K. Prussack, MD Northern Michigan Family Medicine Update June 27, 2019 Disclosures None

Disclaimer: No medications are currently FDA-approved for gender alteration or affirmation. Discussion of treatment is based on expert opinion. Objectives 1. Understand the difference between informed consent and referral letter models for initiating hormone therapy. 2. Access UCSF Guidelines for the Primary and Gender- Affirming Care of Transgender and Gender Nonbinary People. 3. Understand the medications, routes, and doses typically used for feminizing and masculinizing therapy. 4. Understand typical expectations and monitoring for patients on feminizing or masculinizing therapy. Hormone Therapy • Goal to suppress endogenous hormones by providing exogenous hormones • Affects secondary sex characteristics • Masculinizing: testosterone • Feminizing: estrogen, anti-androgen, ?progesterone • Patients may desire surgery of body contours and genitalia • Referral letter vs. informed consent models

Stroumsa et al. Gender affirming treatment ant transition-related care. URL: https://www.youtube.com/watch?v=3ixr0YgB0As WPATH • Incorporated in 1979 as the Harry Benjamin International Gender Dysphoria Association, changed name to World Professional Association for Transgender Health in 2007 • 7th version of Standards of Care (SOC) published in 2012 • Mission to promote evidence based care, education, research, advocacy, public policy, and respect in transgender health.

World Professional Association for Transgender Health, 2016. URL: www.wpath.org WPATH Criteria for Hormone Therapy 1. Persistent, well-documented gender dysphoria 2. Capacity to make a fully informed decision and to consent for treatment 3. Age of majority in a given country (if younger, follow SOC for Puberty-Suppressing Hormones) 4. If significant medical or mental health concerns are present, they must be reasonably well-controlled.

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Gender dysphoria (F64.0) • Discomfort or distress that is caused by a discrepancy between a person’s gender identity and that person’s sex assigned at birth (and the associated gender role and/or primary and secondary sex characteristics) • DSM-V diagnosis, adapted from “sexual identity disorder” (DSM-IV) • Alternatively can use Endocrine disorder, NOS (E34.9) • Different from gender nonconformity (“a person’s gender identity, role, or expression differs from the cultural norms prescribed for people of a particular sex”)

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Gender dysphoria (DSM-V) Lasts at least six months and is shown by at least two of the following: • A marked incongruence between one’s experienced/expressed gender and primary and/or secondary sex characteristics • A strong desire to be rid of one’s primary and/or secondary sex characteristics • A strong desire for the primary and/or secondary sex characteristics of the other gender • A strong desire to be of the other gender • A strong desire to be treated as the other gender • A strong conviction that one has the typical feelings and reactions of the other gender

Parekh, R. What is gender dysphoria? American Psychiatric Association, Feb 2016. URL: https://www.psychiatry.org/patients- families/gender-dysphoria/what-is-gender-dysphoria Referral letter 1. The client’s general identifying characteristics; 2. Results of the client’s psychosocial assessment, including any diagnoses; 3. The duration of the referring health professional’s relationship with the client, including the type of evaluation and therapy or counseling to date; 4. An explanation that the criteria for hormone therapy have been met, and a brief description of the clinical rationale for supporting the client’s request for hormone therapy; 5. A statement that informed consent has been obtained from the patient; 6. A statement that the referring health professional is available for coordination of care and welcomes a phone call to establish this.

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Referral letter • Hormone therapy (?) and breast/chest surgery require one referral letter from a qualified mental health professional • Genital surgery requires two referral letters from qualified mental health professionals

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Informed Consent - WPATH “Initiation of hormone therapy may be undertaken after a psychosocial assessment has been conducted and informed consent has been obtained by a qualified health professional... A referral is required from the mental health professional who performed the assessment, unless the assessment was done by a hormone provider who is also qualified in this area.”

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Informed Consent – Fenway Health “The prescribing provider must make an assessment of each patient’s competency and ability to understand these risks and benefits and make an informed decision. We respect the individual’s sense of self and agency, and will provide cross sex hormone therapy (CSHT) under an informed consent model. However, informed consent does not mean ‘hormones on demand,’ but requires that the prescribing provider, along with the patient, assess for and manage physical and mental conditions which might impact the safety and success of hormone therapy and surgical interventions.”

The Medical Care of Transgender Persons. Fenway Health Transgender Health Program. Fall 2015. URL: https://www.lgbthealtheducation.org/wp-content/uploads/COM-2245-The-Medical-Care-of-Transgender-Persons-v31816.pdf https://fenwayhealth.org/documents/medical/transgender- resources/Fenway_Health_Consent_Form_for_Feminizing_Therapy.pdf https://fenwayhealth.org/documents/medical/transgender- resources/Fenway_Health_Consent_Form_for_Feminizing_Therapy.pdf The The version. th Standards of Carefor Health of the Transsexual, Coleman al. et Coleman Transgender,Nonconformingand Gender People, 7 World Professional Organization for Transgender URL: 2012. Health, www.wpath.org Feminizing Hormone Therapy Contraindications to estrogen: • previous venous thrombotic events related to an underlying hypercoagulable condition • history of estrogen- sensitive neoplasm • end-stage chronic liver disease

Start at low doses and increase gradually at 3-6 months intervals

Permanent

Coleman et al. WPATH SOC. Feminizing Hormone Therapy (T O M) Hormone Initial-lowb Initial Maximum Comments Estrogen If >2mg recommend dividing Estradiol PO/SL 1mg/day 2-4mg/day 8mg/day bid. Max single patch dose available Estradiol transdermal 50mcg 100mcg 100-400 mcg is 100mcg. Frequency of change is product dependent. Estradiol valerate IMa <20mg IM q2 wk 20mg IM q2wk 40mg IM q2wk May divide dose to weekly. Estradiol cypionate <2mg q 2wk 2mg IM q2wk 5mg IM q2wk May divide dose to weekly. IM Androgen blocker Spironolactone 25mg qd 50mg bid 200mg bid Finasteride 1mg qd 5mg qd Dutasteride 0.5mg qd

Test Baseline 3 mo. 6 mo. 12 mo.Yearly PRN Comments BUN/Cr/K+ X X X X X X Only w/spironolactone Lipids Per USPSTF X Otherwise no evidence A1c or glucose Per USPSTF X Otherwise no evidence Estradiol XX X Total Testosterone XXX X Sex Hormone Optional to calculate XXX X Binding Globulin bioavailable testosterone

Albumin XXX X“ Only if symptoms of Prolactin X prolactinoma

Center of Excellence for Transgender Health, Department of Family and Community Medicine, University of California San Francisco. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People; 2nd edition. Deutsch MB, ed. June 2016. Progesterone • No evidence for or against • Anecdotes of improved breast development, mood and libido • ?Risk of breast cancer, cardiovascular disease • Medroxyprogesterone acetate (Provera) 2.5mg-10mg qHS • Micronized progesterone (Prometrium) 100-200mg qHS (theoretical risk of direct androgenizing effect)

Goal of therapeutic levels at onset of hormone therapy

Permanent

Coleman et al. WPATH SOC. Masculinizing Hormone Therapy (T O M) Androgen Initial – low Initial Maximum Comment Testosterone Cypionate 20 mg/week 50mg/week 100mg/week May double for q2wk IM/SQ Testosterone Enthanate 20mg/week 50mg/week 100mg/week " IM/SQ Testosterone topical gel 12.5-25 mg Q May come in pump or 50mg Q AM 100mg Q AM 1% AM packet Testosterone topical gel 40.5 - 60.75mg 20.25mg Q AM 103.25mg Q AM " 1.62% Q AM Patches come in 2mg and Testosterone patch 1-2mg Q PM 4mg Q PM 8mg Q PM 4mg size; may cut Testosterone cream 10mg 50mg 100mg Needs to be compounded Testosterone axillary gel Comes in pump only, one 30mg Q AM 60mg Q AM 90-120mg Q AM 2% pump = 30mg

Test Baseline 3 mo. 6 mo. 12 mo.Yearly PRN Comments Lipids Per USPSTF X Otherwise no evidence A1c or glucose Per USPSTF X Otherwise no evidence Estradiol XX X Total Testosterone XXX X Sex Hormone Optional to calculate XXX X Binding Globulin bioavailable testosterone

Albumin XXX X“ Hemoglobin & X XX X X Hematocrit

Center of Excellence for Transgender Health, Department of Family and Community Medicine, University of California San Francisco. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People; 2nd edition. Deutsch MB, ed. June 2016. Masculinizing Hormone Lab Monitoring • Measure total testosterone at midpoint between injections • Can calculate free testosterone using SHBG and albumin in cases that are not straight-forward • Calculator: http://www.issam.ch/freetesto.htm • Can consider following liver function tests

Center of Excellence for Transgender Health, Department of Family and Community Medicine, University of California San Francisco. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People; 2nd edition. Deutsch MB, ed. June 2016. Criteria for Puberty-Suppressing Hormones 1. The adolescent has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed); 2. Gender dysphoria emerged or worsened with the onset of puberty; 3. Any coexisting psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment;

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Criteria for Puberty-Suppressing Hormones 4. The adolescent has given informed consent and, particularly when the adolescent has not reached the age of medical consent, the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.

Coleman et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, 7th version. The World Professional Organization for Transgender Health, 2012. URL: www.wpath.org Surgical Treatment • Top surgeries and bottom surgeries • Voice and facial surgeries • Primary care may be front lines for surgical follow-up • Examine for healing • High risk of UTIs and urinary problems University of Michigan Resources • Comprehensive Gender Services Program: 734-998-2150 or [email protected] • Mental Health Resources • Referrals to Primary Care, Hormone Prescribers, Surgeons, Speech Therapy • Support Groups: Over 30, Parents, Partners, Transgender Teens, Trans-Masculine, Trans- Feminine

URL: http://www.uofmhealth.org/conditions-treatments/transgender-services Comprehensive Gender Services Program

http://www.med.umich.edu/pdf/transgender/Service-Inquiry-Form.pdf University of Michigan Resources • Reproductive Endocrinology: Dr. John Randolph • Plastic Surgery: Dr. William Kuzon • Urology: Dr. Dana Ohl • Family Medicine: PCPs at all clinic sites • Corner Health Center: Dr. Anita Hernandez • Adolescent Health Initiative • Voices of Transgender Adolescents in Health Care https://www.youtube.com/watch?v=CHN3YhMi-5A University of Michigan Resources Pediatric Gender Management Program at Mott Dr. Daniel Shumer, Endocrinology [email protected] Sara Wiener, Social Work [email protected] Dr. Ellen Selkie, Adolescent Medicine [email protected] Dr. Joanna Quigley, Child Psychiatry [email protected] http://www.mottchildren.org/conditions-treatments/gender- management Community Resources • Integrative Empowerment Group Ann Arbor/Ypsilanti; 734-945-6210 Counseling, therapy, yoga with LGBTQ expertise • Ozone House Ann Arbor/Ypsilanti; Crisis Line 734-662-2222 Youth shelter, drop-in center, positive programming • Ruth Ellis Center Highland Park; 313-252-1950 Residential and drop-in, mental health services, education • Spectrum Center Ann Arbor; 734-763-4186 Support center for LGBTQ students at University of Michigan Community Resources • Planned Parenthood of Michigan Ferndale and other locations; 248-399-5900 Sexual healthcare for all people • Riot Youth/Neutral Zone Ann Arbor; 734-214-9995 Programs for high school students in arts, music, education, leadership • Unified Detroit/Ypsilanti/Jackson; 734-572-9355 HIV testing, condoms, behavioral health, housing assistance, support groups • Michigan Organization on Adolescent Sexual Health (MOASH) Lansing; 517-318-1414 Health resources geared towards youth Community Resources • Stand with Trans Farmington; https://facebook.com/standwithtrans Community building, engaging trans youth and allies • Affirmations Ferndale; 248-398-7105 Community spaces and activities, support groups, wellness classes • Youthville Detroit Detroit; 313-869-2200 Groups, activities, leadership programs; health center for patients 10-21yo • Trans Lifeline 877-565-8860 Hotline staffed by transgender people for transgender people