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PART THREE - The Full Text of the Standards of Care

IX. Hormone Therapy for Adults

Reasons for Hormone Therapy. Cross-sex hormonal treatments play an important role in the anatomical and psychological gender transition process for properly selected adults with gender identity disorders. These hormones are medically necessary for rehabilitation in the new gender. They improve the quality of life and limit psychiatric co-morbidity which often accompanies lack of treatment. When physicians administer androgens to biologic females and estrogens, progesterone, and/or testosterone-blocking agents to biologic males, patients feel and appear more like members of their aspired-to sex.

The Desired Effects of Hormones. Biologic males treated with cross-sex hormones can realistically expect treatment to result in: breast growth, some redistribution of body fat to approximate a female body habitus, decreased upper body strength, softening of skin, decrease in body hair, slowing or stopping the loss of scalp hair, decreased fertility and testicular size, and less frequent, less firm erections. Most of these changes are reversible, although breast enlargement will not completely reverse after discontinuation of treatment.

Biologic females treated with cross-sex hormones can expect: a permanent deepening of the voice, permanent clitoral enlargement, mild breast atrophy, increased upper body strength, weight gain, facial and body hair growth, male-pattern baldness, increased social and sexual interest and arousability, and decreased hip fat.

The degree of desired effects actually attained varies from patient to patient. The maximum physical effects of hormones may not be evident until two years of continuous treatment. Heredity limits the tissue response to hormones and cannot be overcome by increasing dosage.

Medical Side Effects. Side effects in biologic males treated with estrogens may include increased propensity to blood clotting (venous thrombosis with a risk of fatal pulmonary embolism), development of benign pituitary prolactinomas, infertility, weight gain, emotional lability and liver disease. Side effects in biologic females treated with testosterone may include infertility, acne, emotional lability (including the potential for major depression), increases in sexual desire, shift of lipid profiles to male patterns which increase the risk of cardiovascular disease, and the potential to develop benign and malignant liver tumors and hepatic dysfunction. Patients with medical problems or otherwise at risk for cardiovascular disease may be more likely to experience serious or fatal consequences of cross-sex hormonal treatments. For example, cigarette smoking, obesity, advanced age, heart disease, hypertension, clotting abnormalities, malignancy, and some endocrine abnormalities are relative contraindications for the use of hormonal treatment. Therefore, some patients may not be able to tolerate cross-sex hormones. However, risk-benefit ratios should be considered collaboratively between the patient and prescribing physician.

Social Side Effects. There are often important social effects from taking hormones which the patient must consider. These include relationship changes with family members, friends, and employers. Hormone use may be an important factor in job discrimination, loss of employment, divorce and marriage decisions, and the restriction or loss of visitation rights for children. The social effects of hormones, however, can be positive as well.

The Prescribing Physician's Responsibilities. Hormones are to be prescribed by a physician. Hormones are not to be administered simply because patients demand them. Adequate psychological and medical assessment are required before and during treatment. Patients who do not understand the eligibility and readiness requirements and who are unaware of the SOC should be informed of them. This may be a good indication for a referral to a mental health professional experienced with gender identity disorders.

The physician providing hormonal treatment and medical monitoring need not be a specialist in endocrinology, but should become well-versed in the relevant medical and psychological aspects of treating persons with gender identity disorders.

After a thorough medical history, physical examination, and laboratory examination, the physician should again review the likely effects and side effects of this treatment, including the potential for serious, life-threatening consequences. The patient must have the cognitive capacity to appreciate the risks and benefits of treatment, have his/her questions answered, and agree to medical monitoring of treatment. The medical record must contain a written informed consent document reflecting a discussion of the risks and benefits of hormone therapy.

Physicians have a wide latitude in what hormone preparations they may prescribe and what routes of administration they may select for individual patients. As therapeutic options rapidly evolve, it is the responsibility of the prescribing physician to make these decisions. Viable

options include oral, injectable, and transdermal delivery systems. Topically applied hormonal creams have not been shown to produce adequate cross-sex effects. The use of transdermal estrogen patches should be considered for males over 40 years of age or those with clotting abnormalities or a history of venous thrombosis.

In the absence of any other medical, surgical, or psychiatric conditions, basic medical monitoring should include: serial physical examinations relevant to treatment effects and side effects, vital sign measurements before and during treatment, weight measurements, and laboratory assessment. For those receiving estrogens, the minimum laboratory assessment should consist of a pretreatment free testosterone level, fasting glucose, liver function tests, and complete blood count with reassessment at 6 and 12 months and annually thereafter. A pretreatment prolactin level should be obtained and repeated at 1, 2, and 3 years. If hyperprolactemia does not occur during this time, no further measurements are necessary.

For those receiving androgens, the minimum laboratory assessment should consist of pretreatment liver function tests and complete blood count with reassessment at 6 months, 12 months, and yearly thereafter. Yearly palpation of the liver should be considered. Patients should be screened for glucose intolerance and gall bladder disease.

Biological males undergoing estrogen treatment should be monitored for breast cancer and encourage in engage in routine self-examination. As they age, they should be monitored for prostatic cancer. Females who have undergone mastectomies who have a family history of breast cancer should be monitored for the disease. Gender patients, whether on hormones or not, should be screened for pelvic malignancies as are other persons.

Physicians should provide their patients with a brief written statement indicating that this person is under medical supervision which includes cross-sex hormone therapy. During the early phases of hormone treatment, the patient should be encouraged to carry this statement at all times to help prevent difficulties with the police.

Reductions in Hormone Doses After Gonadectomy. Estrogen doses in post-orchiectomy patients can often be reduced by 1/3 to ½ and still maintain feminization. Reductions in testosterone doses post-oophorectomy should be considered, taking into account the risks of osteoporosis. Lifelong maintenance treatment is usually required in both sexes.

The Misuse of Hormones. Some individuals obtain hormones from nonmedical sources, such as friends, family members, and pharmacies in other countries. These treatments are often excessive in dose, produce more side effects, are medically unmonitored, and expose the person to greater medical risk. Persons taking medically monitored hormones have been known to take additional doses of illicitly obtained hormones without their physician's knowledge. Mental health professionals and prescribing physicians should inquire whether their patients have increased their

doses and make a reasonable effort to enhance compliance in order to limit medical and psychiatric morbidity from treatment. It is ethical for physicians to discontinue taking medical and legal responsibility for patients who place themselves at higher risk by noncompliance with the prescribed hormonal regimen. Patient pressure is not a sufficient reason to deliver substandard medical care.

Other Potential Benefits of Hormones. Hormonal treatment, when medically tolerated, should precede any genital surgical interventions. Satisfaction with the hormone's effects consolidates the person's identity as a member of the aspired-to gender and further adds to the conviction to proceed. Dissatisfaction with hormonal effects may signal ambivalence about proceeding to surgical interventions. Hormones alone often generate adequate breast development, precluding the need for augmentation mammaplasty. Some patients who receive hormonal treatment will not desire surgical interventions.

The Use of Antiandrogens and Sequential Therapy. Antiandrogens can be used as adjunctive treatments in biologic males receiving estrogens, even though they are not always necessary to achieve feminization. In some patients, antiandrogens may offer assistance by more profoundly suppressing the production of testosterone and enabling a lower dose of estrogen to be used when adverse estrogen side effects are anticipated.

Feminization does not require sequential therapy. Attempts to mimic the menstrual cycle by prescribing interrupted estrogen therapy or substituting progesterone for estrogen during part of the month are not necessary to achieve feminization.

Informed Consent. Hormonal treatments should be provided only to those who are legally able to provide informed consent. This includes persons who have been declared by a court to be emancipated minors and incarcerated persons who are considered competent to participate in their

medical decisions. For adolescents, informed consent needs to include the minor patient's assent and the written informed consent of a parent or legal guardian. Informed consent implies that the patient understands that hormone administration limits fertility and the removal of sexual organs prevents the capacity to reproduce.

Hormonal Treatment of Prisoners. Patients who are receiving hormonal treatments as part of a medically monitored program of gender transition should continue to receive such treatment while incarcerated to prevent emotional lability, reversibility of physical effects, and the sense of desperation that may include depression and suicidality.

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