Protocols for Hormonal Reassignment of Gender

 

Chenit Flaherty, RN., Jim Franicevich, FNP., Mark Freeman, FNP.,
Pam Klein, RN., Lori Kohler, MD., Clara Lusardi, HW., Linette Martinez, MD.,
Mary Monihan, RN., Jody Vormohr, MD., Barry Zevin, MD.,
The Tom Waddell Center.
[Abstract]  Full Text  [PDF]

 

Patients presenting with gender identity disorders may be appropriate for hormonal reassignment of gender. Standards for who is appropriate for treatment are outside of the scope of this document but are available (see Harry Benjamin International Gender Dysphoria Association Standards of Care (http://www.hbigda.org/), Transgender Care Recommended Guidelines). Our clinic’s protocols cover issues related to hormonal reassignment of gender for male-to-female (MTF) and female-to-male (FTM) patients. [sections relating specifically to MTF issues are not reproduced here. Please download the PDF file from the Tom Waddell Clinic website for such information].

The purpose for writing these protocols is to share our experience with providers and their patients with the goals on expected results, and risks of therapy.

As medical providers, we are concerned first and foremost with the safety and health of our patients. No medical treatment is entirely harmless, but we aim to minimize harm to our patients. Hormonal reassignment of gender has undergone some scientific study and where scientific knowledge is present, it guides these protocols. Unfortunately, a great deal has not been studied, and this allows for some uncertainty in our medical practice. It is therefore of utmost importance that we inform our patients of the risks and benefits of treatment and of the aspects of treatment in which uncertainty exists. All patients are required to give informed consent to the procedure of hormonal reassignment of gender. A patient’s ability to understand and consent to the process, its risks and expected results, is an absolute requirement prior to starting treatment. In our practice, hormonal reassignment of gender is provided as a component of comprehensive primary health care.

Background

November of 1994 marked the initiation of Transgender Tuesdays. It was perhaps the first time a public health department had created a clinic specifically dedicated to reaching patients who self identified as transgender. The Health Department acted in response to a felicitous combination of eagerness on the part of Tom Waddell Health Center’s busy, multi-disciplinary HIV team, and the concurrent urging of several community organizations which already had working relationships with the HIV clinic. These organizations included: the Tenderloin AIDS Resource Center, Brothers’ Network, Asian AIDS Project (now API Wellness Center), and Proyecto Contra-SIDA Por Vida, FTM International. Assorted transgender activists and other community providers also helped make the clinic a reality.

The rationale that eventually won the Health Department over was fairly simple. There exists a large group of individuals who are at risk for HIV transmission, and who are also in need of general primary care services. This group is known to be averse to accessing medical services for a number of reasons, including: prior negative experience in clinic settings, expectation of discriminatory treatment, the requirement of psychiatric treatment and approval for traditional gender-reassignment treatment, and, in some cases, reticence to reveal illegal occupational activities to authorities. Yet many in this group actively pursue pharmaceuticals on a regular basis, most notably hormones or “silicone” injections purchased on the street. A few unscrupulous medical practitioners also provide hormones, yet they do not bother to monitor their patients health via physical and laboratory exams.

It was argued that by offering a range of services that included the possibility of hormonal therapy, members of this group might be brought in to access primary medical care. The clinic was scheduled for a weekday evening so as to be especially accessible to commercial sex workers. In the subsequent six and a half years since its inception, this targeted primary care clinic at Tom Waddell Health Center in San Francisco’s famed Tenderloin District has seen nearly 700 patients.

Our clinic’s target population is self-defined transgender people; we do not require clients to present any documentation attesting to their transgender status. All prospective patients meet first with a nurse who completes a preliminary assessment of the person’s appropriateness for the clinic. The nurse also identifies highly at-risk patients (those with immediate illness or homelessness for instance) and expedites their intake process. The nurse schedules a psychosocial intake interview and a first time provider visit. The team meets regularly to discuss issues and plans of action for individual patients.

We tell patients that we are not a surgery clinic, nor do we provide psychiatric approval for surgery. Rather, we are a Primary Care clinic available to meet all of their general medical needs. We also clarify that we discourage outside hormone purchase or use, and we will prescribe based on protocols designed to have the desired effect with a minimum of undesirable side effects. However, we do not turn patients away due to their use of street hormones or other drugs. Our standard for prescribing hormones is one of informed consent, which includes mental capacity to understand possible risks as well as limits to benefits. Our rationale is one of harm reduction.

In addition to regular visits with a Primary Care provider, clients may take advantage of on-site auxiliary services including: urgent care, a licensed nutritionist, acupuncture, a smoking-cessation group, and an ongoing peer support group with supervision by our social worker. At times, researchers are on-site providing an opportunity for patients to participate in research studies.

I. Treatment Principles

A. Patient’s desired outcomes

Each patient has his or her own specific idea or definition of what it is to be transgender or what a transgender person needs. It is essential to explore these ideas and definitions, as patients often have specific goals and expectations in mind when they are in the process of transitioning from one gender to another. Some common desires include:

2. For FTM

• Facial hair with or without body hair
• Increased body musculature
• Maintain a strong transgender identity
• Maintain a strong male identity
• Mastectomy
• Phalloplasty
• No surgery
• Masculine body

Treatment should be individualized for each patient. Patients often have unrealistic expectations and education about what to expect from treatment is imperative in the first visits. The use of estrogen has potentially serious and life-threatening adverse effects. The medical provider should obtain a signed consent indicating agreement and understanding of treatment from the patient. The process of hormonal reassignment is slow; maximum effects may be achieved after 2-3 years of therapy.

B. Health care provider’s desired outcome

• Increased overall health and well-being
• Increased trust and ability to overcome previous negative experiences in medical systems
• Adherence to advice regarding lab tests, office visits etc.
• Discussion of harm reduction regarding substance use, sexual practices, occupational sex work
• Discussion of HIV risk and testing
• Patient benefits by supportive comprehensive primary care.
• Serve as a link between the patient and social, medical, psychological and educational opportunities of main society

C. Healthcare upon initiating care

• Psychosocial intake
• Baseline labs: CBC with differential, liver panel, renal panel, glucose, hepatitis B total core ab, Hepatitis C ab, VDRL (or RPR), lipid profile, prolactin level, Urine GC and Chlamydia.
• Review health care maintenance including: immunizations, TB screening, safety and safer sex counseling, and HIV testing if appropriate
• Address medical problems as needed
• Discuss patients goals and expectations for therapy
• Review side effects, risks and benefits of hormone therapy and obtain informed consent
• Prescribe medications and follow patients per protocols

D. At every visit

• Assess for desired and adverse effects of medication
• Check weight, blood pressure
• Review health maintenance
• Directed physical exam as needed

E. HIV Disease and transgender people

HIV infection is unfortunately prevalent among the transgender population. There is no evidence in the medical literature or in our experience that the natural history of HIV disease differs in transgender people. HIV is not a contraindication or precaution for any of our protocols. While drug-drug interactions may occur, we know of no specific dangerous interactions or likely causes of drug failure. Treatment with hormones is frequently an incentive for patients to address their HIV disease and providers of care for transgender people should enhance their HIV expertise.

F. Consent

The use of medications for gender reassignment is off-label. There are potentially life-threatening complications. The medical provider should obtain a signed consent indicating agreement to and understanding of treatment from the patient.

V. FTM Treatment Protocol

The main available treatment for hormonal reassignment for FTM patients are androgens which usually produce satisfactory virilizing results. The entire process of virilization can take years to complete. However, in many patients, changes in voice pitch, muscle mass, and hair growth become apparent after just a few months of a regular hormonal treatment regimen.

A. Testosterone

^{1. Available forms of testosterone and dosing}

a) Intramuscular Route

• Testosterone Cypionate 100 - 400 mg IM Q 2-4wks
• Testosterone Enanthate 100-400 mg IM Q 2 -4 wks
• Testosterone Propionate 100-200 mg IM 1-2 times/wk.

IM testosterone is released slowly from the muscle. There are variations in the plasma concentration through injection cycles, causing symptoms that may require dose or frequency changes.

b) Transdermal System

• Androderm patch (2.5mg/patch), 1-2 patches/day. This is a non-scrotal patch. It has the advantage of avoiding peak ups and downs in testosterone levels, thus delivering a constant dose of hormone. This form can be an effective alternative in patients who are more sensitive to variable testosterone levels.
• Testosterone ointment in petrolatum base 2-4%. Used as an adjuvant to increase concentration in local areas (face, clitoral area). Mixed results in terms of effectiveness.
• Androgel (testosterone gel 1%). Avoid the use of the patch . Need to be used with caution at the possibility of exposing partners and loss of absorption.

c) Oral preparations (Methyl/testosterone; Oxandrolone)

These are not used in our clinic. PO preparations undergo extensive liver metabolism, increasing the possibility of liver complications.

^{2. Contraindications}
Hx of coronary uncontrolled artery disease, pregnancy.

^{3. Precautions}
Hyperlipidemia, liver disease, cigarette smoking, obesity, family history of coronary artery disease, family history of breast cancer, acne, history of deep venous thrombosis, erythrocytosis.

^{4. Masculinizing effects}

• Cessation of menses
• Voice change to a male range
• Increased hair growth on face, chest, and extremities
• Increased muscular mass and strength
• Clitoral enlargement

Note: Changes in voice range, hair follicles, and clitoral size are permanent. Other effects are reversible at the cessation of hormonal therapy.

^{5. Other Effects}

• Protection against osteoporosis
• Increased libido
• Increased physical energy

^{6. Possible adverse effects}

• Increased weight
• Peripheral edema
• Acne
• Erythrocitosis
• Liver enzyme elevations
• Decrease in the HDL fraction of cholesterol
• Increased risk of cardiovascular disease
• Coarsening of skin
• Headache
• Emotional changes, increased aggressiveness
• Redistribution of body fat to an android (apple) shape
• Male pattern baldness
• Increased risk of breast cancer
• Hypertension
• Thrombophlebitis

^{7. Drug Interactions (See Attachment: Drug Interactions)}

• Potentiation of warfarins.
• In diabetic patients, blood sugar decreases, requiring adjustments in dose of hypoglycemic agents.

^{8. Special Considerations}

• Smoking cessation should be strongly encouraged to decrease cardiac risk factors
• Any vaginal bleeding after cessation of menses should be evaluated as post menopausal bleeding.
• Circulating testosterone has been associated with breast cancer. Breast exams and mammograms are essential. Any post-surgical residual axillary breast tissue requires regular examination as well.
• Pap smears are still important follow-up.
• Assess for hypersexual behavior and safe sex practices.

DRUG INTERACTIONS

Testosterone increases the hypoglycemic effect of Sulfonylureas and the anticoagulant effect of Warfarin

Citation: August 14 2001; Original Article by The Tom Waddell Center Transgender Team