The Transgender Patient and Medications Deb Thorp, MD Medical Director Park Nicollet Gender Services Clinic Dr. Thorp indicated no potential conflict of interest to this presentation. She does intend to discuss the unapproved/investigative use of cross-gender hormones for transgender patients. Objectives At the end of this presentation, the audience member will be able to: 1. Discuss when to consider starting cross gender hormones 2. Typical doses of cross-gender hormones 3. Common medication interactions 4. Not-so-common contra-indications 5. What monitoring is required
Disclosures I have no financial interest in any pharmaceutical or medical device company I do intend to discuss off-label uses of medications Terminology Gender is how we present in the world, how we identify, the stereotypical roles we choose (or not) to fulfill. It may or may not match our sex. When it doesn t match our sex, there is Gender Non-conformity. There may or may not be Gender Dysphoria. When there is Gender Dysphoria, it may or may not be strong enough to require treatment with hormones and/or surgery. Society has traditionally thought of this as a binary concept, it s really a concept on a spectrum. Gender can also be a legal term (i.e., the gender marker on your ID) Sex is our phenotype the biologic reproductive parts we were born with. Also known as birth sex or sex assigned at birth Intersex, or disorders of sexual development, are those individuals with phenotypic features of both sexes
Terminology Approach to Care Care is very individualized, depending on the degree of gender dysphoria manifested by various aspects of a person s mental and medical health, resulting in a wide variety of bodies and expressions. Some patients need hormones, no surgery Some patients need surgery, no hormones Some patients need neither Some patients need both
Approach to Care Treatment goal is to decrease the dysphoria, usually with a combination of transitional treatments: Social transition is the process by which the person alters their outward gender presentation, usually supported by psychotherapy Medical transition is the process by which hormones and/or surgery are used to change outward appearances, enabling a more congruent gender presentation Elements of Transition Social transition is facilitated with support from family, friends, school, work, mental health therapists, etc. Medical transition is the combination of cross-gender hormones, endogenous hormone blockade, surgery Hormones are mostly provided by primary care clinicians Surgery is done mostly by plastic surgeons, with consultation with OB/GYN, Urology as needed
When to consider starting cross-gender hormones WPATH (World Professional Association for Transgender Health) statement on eligibility and readiness: Patient has long standing gender dysphoria Patient is capable of giving informed consent Patient is of legal age (if not, use criteria for adolescents and children) Patient has adequately controlled physical and mental health comorbidities, if present Masculinizing Medical Treatment Injectable Testosterone Cypionate or Enanthate typical dose of 60-80 mg IM weekly Topical Testosterone Gels in 1 or 1.62% - typical dose of 5-7.5 mg daily Testosterone Undecanoate (Aveed) 750 mg every 10 weeks (EXPENSIVE!) Testosterone Pellets (Testopel) inserted every 4 months (EXPENSIVE!) May add DepoProvera or Mirena IUD for menstrual management or contraception
Monitoring Masculinizing Hormones The goal is to achieve physiologic levels of testosterone to facilitate masculinizing effects Free and/or total testosterone levels in normal male range Watch for: Elevated RBC count based on normal male ranges Elevated LFTs Worsening lipids Elevated glucose levels Timeline of Expected Physical Changes Facial hair growth can start as soon as 4-6 months in, but takes 5+ years to achieve full beard Body hair growth starts in 3-4 months, but continues to increase throughout life Clitoromegaly starts in 3-4 months, levels off by 1 year Amenorrhea usually accomplished by 6 months
Timeline of Expected Physical Changes Voice changes start in 6 months, levels off by 2 years Acne can start within 6 weeks Balding can start at 1 year, but risk continues for life Fat and muscle changes start within 3-6 months, can continue for life Risks of masculinizing therapy Good evidence: Central adiposity Weight gain Sleep apnea Increased diabetic risk Hypertension Increased lipids Increased cardiovascular risk over baseline female risks Acne
Risks of masculinizing therapy Controversial: Increased risk thromboembolic disease Decreased bone density Increased risk of breast cancer Increased risk of endometrial cancer Increased liver enzymes Decreased stability of bipolar disease, ADHD No Evidence: Increased risk ovarian cancer Masculinizing Surgical Treatments Top surgery is male chest contouring with subtotal mastectomy and usually nipple/areolar re-positioning Bottom surgery is either Metoidioplasty or Phalloplasty
Case Discussion 24 year old patient, assigned female sex at birth, not comfortable with female gender presentation since childhood, has the following medical history: Menorrhagia with severe dysmenorrhea Depression, currently on Prozac 40 mg daily Anxiety, treated with Prozac (and weed) Tobacco abuse, smoking 1 pack per day, with generous amounts of alcohol and weed also used Case Discussion Family not supportive Friends very supportive Working part time at gas station, going to school part time, but having difficulty leaving the house alone Voice is very feminine, causes distress
Feminizing Medical Treatment Estrogens Patches: Typically need total of 0.2 to 0.4 mg Gels: Almost never covered by insurance now Oral Estradiol: 2-8 mg daily, use sublingually Injectable Estradiol Valerate 2-10 mg weekly Injectable Estradiol Cypionate 1-5 mg weekly Feminizing Medical Treatment Anti-Androgens Spironolactone 50-200 mg daily in divided doses Finasteride 5 mg daily Dutasteride 0.5 mg daily Bicalutamide 50 mg daily (avoid if possible due to liver toxicity potential) Cyproterone 1 mg daily (not available in US, but sold on line)
Feminizing Medical Treatment Progestins Prometrium 200 mg nightly Provera 5-10 mg daily DepoProvera 150 mg every 3 months Norethindrone 5 mg daily Progestins are controversial, and not used in everyone Monitoring Feminizing Therapy Goal is full testosterone suppression to normal or less than normal female levels which facilitates feminizing changes, without such high levels of estrogen that concern for thrombotic risk and/or mental health destabilization occurs BMP to follow renal function when on spironolactone ALT to look for liver dysfunction from any of the medications Prolactin to look for pituitary hyperplasia/adenomas
Monitoring Feminizing Therapy Watch for: Increased lipids, especially triglycerides in oral administration Increased diabetic risks Worsening migraines Signs of thromboembolic disease Mood destabilization, especially with addition of progestin Timeline of Feminizing Changes Breast growth in 3-6 months, stabilizes at 18-24 months Fat re-distribution in 3-6 months Decreased muscle mass in 3-6 months Decreased acne, softer skin in 3-6 months Decreased facial/body hair growth in 3-12 months Decreased libido/erectile function/fertility in 1-6 months
Risks of Feminizing Medical Treatment Good Evidence: Thromboembolic events May not really be increased much with transdermal therapy Cardiovascular events Increased diabetic risk Increased hypertension risk Increased lipids, especially triglycerides Increased weight Risks of Feminizing Medical Treatment Good Evidence Gallbladder disease with oral estrogen therapy Decreased or no fertility, potentially permanently
Risks of Feminizing Medical Treatment Controversial: Mood destabilization Worsening migraines Increased breast cancer risk Prolactinoma Decreased bone density Feminizing Surgical Treatments Breast Augmentation Facial Feminization Surgery Tracheal Shave Mechanical Hair Removal Orchiectomy Bottom Surgery : Penectomy with orchiectomy, vaginoplasty
Case Discussion 55 YO patient, assigned male at birth, has been on selfadministered hormones for the last year, but doesn t feel well and wonders if it s the medications? Medical history significant for PTSD after serving in Gulf War, Tobacco abuse (one pack per day) obesity with BMI 35, hypertension, appendectomy. Occasional alcohol use. Current complaints: some shortness of breath with exertion, fatigue, nausea, headaches Case Discussion Divorced twice, has 2 grown kids that the patient sees a few times a year Has a girlfriend who has pushed the patient into seeking medical care to treat the gender dysphoria under supervision, is supportive of patient transitioning Working full time doing project management for a local consulting company Current hormone regimen: Premarin 4 tablets daily(purple ones), and shots when she can get them, Provera 10 mg daily, spironolactone 200 mg daily and cyproterone (unknown dose)
Case Discussion Workup for medical complaints has found that the patient has mild COPD, is hypertensive, has sleep apnea, and a triglyceride level of 450, fasting glucose of 110, but no currently immediately life threatening conditions. What would be the best choice for a medication regimen? Resources DSM-5 Gender Dysphoria in Adolescents and Adults (American Psychiatric Association, 2012) Marked incongruence 6 mo between experienced/expressed & assigned gender including 2 of following: Marked incongruence between experienced/expressed gender and primary and/or secondary sex characteristics (or anticipated ones in young adolescents). Strong desire to be rid of primary and/or secondary sex characteristics because of marked incongruence with experienced/expressed gender (or desire to prevent development anticipated secondary sex characteristics in young adolescents). Strong desire for primary and/or secondary sex characteristics of other gender. Strong desire to be of the other gender (or an alternative one from assigned one). Strong desire to be treated as the other gender (or an alternative one from assigned one) Strong conviction that one has typical feelings & reactions of the other gender (or an alternative one from assigned one) Also: distress or impairment in social, school, or other important areas www.lgbthealtheducation.org
Resources DSM-5 Gender Dysphoria in Children (American Psychiatric Association, 2012) Marked incongruence 6 mo between experienced/expressed & assigned gender including strong desire/preference for 6 of following: Strong desire to be or insistence one is the other gender (or some alternative) different from assigned one (mandatory characteristic). Strong preference for cross-dressing in or simulating female attire (assigned boys); or only masculine clothing/resistance wearing feminine clothing (assigned girls). Strong preference for cross-gender roles in make-believe/fantasy play Strong preference for toys, games, or activities stereotypically used/played by other gender. Strong preference for playmates of the other gender Strong rejection of typically masculine toys/games/activities & strong avoidance of rough-and-tumble play (assigned boys); or strong rejection of typically feminine toys, games, and activities (assigned girls) Strong dislike of one s sexual anatomy Strong desire for the primary and/or secondary sex characteristics that match one s experienced gender Also: distress or impairment in social, school, or other important areas www.lgbthealtheducation.org Resources Local (Medical): Park Nicollet Gender Services Clinic HealthPartners has individuals providing Transgender Care University of Minnesota Program in Human Sexuality/Center for Sexual Health Family Tree (Sliding Scale) HCMC s Gender Clinic for Children
Resources Local (Medical/Mental Health/Advocacy): Children s Hospital (Christopher Dunne, MD in Peds Endocrinology and Angela Goepford, MD in General Peds) Smiley s Clinic United Family Medicine Clinic Reclaim Family Partnership Rainbow Health Initiative Outfront MN Resources National (Medical/Mental Health) Fenway Health National LGBT Health Education Center WPATH (World Professional Association for Transgender Health) Center of Excellence for Transgender Health AACAP (American Association of Child and Adolescent Psychiatry) AAFP (American Academy of Family Practice) Transgender Health Journal
Resources National (Advocacy) PFLAG GLSEN SAGE HRC National Center for Transgender Equality Transgender Law Center References Webinar: Meeting the Healthcare Needs of Transgender People put on by National LGBT Health Education Center Webinar: Caring for Gender Dysphoric Children and Adolescents put on by National LGBT Health Education Center Chen D, Hidalgo MA, Leibowitz S, Leininger J, Simons L, Finlayson C, Garofalo R. Multidisciplinary Care for Gender-Diverse Youth: A Narrative Review and Unique Model of Gender-Affirming Care Transgender Health 2016; 1:117-123
References Sineath RC, Woodyaa C, Sanches T, Giammattei S, Gillespie T, Hunkeler E, Owen-Smith A, Quinn VP, Roblin D, Stephenson R, Sullivan PS, Tangpricha V, Goodman M. Determinants of and Barriers to Hormonal and Surgical Treatment Receipt Among Transgender People Transgender Health 2016;1:129-136 Irvig MS. Testosterone therapy for transgender men Lancet DiabEndo OnLine 4-12-16. Coleman E, et al. WPATH Standards of Care Version 7 References Schechter L. Gender Confirmation Surgery: An Update for the Primary Care Provider Transgender Health 2016;1:32-40 Burkhalter JE, et al. The National LGBT Cancer Action Plan: A White Paper of the 2014 National Summit on Cancer in the LGBT Communities LGBT Health 2016;3:19-31 Cahill SR, Baker K, Deutsch MB, Keatley J, Makadon HJ. Inclusion of Sexual Orientation and Gender Identity in Stage 3 Meaningful Use Guidelines: A Huge Step Forward for LGBT Health LGBT Health Published on line December, 2015
References Lelutiu-Weinberger C, Pollard-Thomas P, Pagano W, Levitt N; Lopez EI, Golub SA, Radix AE. Implementation and Evaluation of a Pilot Training to Improve Transgender Competency Among Medical Staff in an Urban Clinic Transgender Health 2016;1:45-53 Shipherd JC, et al. Interdisciplinary Transgender Veteran Care: Development of a Core Curriculum for VHA Providers Transgender Health 2016;1:54-62 White Hughto JM, Reisner SL. A Systematic Review of the effects of Hormone Therapy on Psychological Functioning and Quality of Life in Transgender Individuals Transgender Health 2016;1:21-31 Garofalo R. Focusing on Transgender Healthcare Transgender Health 2016;1:1-3