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Overview of Testosterone-Based GAHT

Testosterone is used to reduce estrogen-related features, induce testosterone-related features, and relieve gender-related distress. Generally, the desired effects of testosterone-based GAHT include deepened voice, cessation of monthly bleeding, clitoral growth, increased muscle mass, fat redistribution, and hair growth in androgen-dependent areas, including facial hair. A patient may also lose chest tissue glandularity, but generally does not lose mass or hemicircumference.

 

Voice deepening is considered an irreversible change. Should the patient wish for a deeper change in their voice than has been achieved through GAHT, they may benefit from voice therapy with a qualified and supportive speech and language therapist who can work with the patient to modify their vocal characteristics. Currently  speech and language therapist services are not covered in NB for transition-related purposes. For more information about SLP services in NB go here

 

Clitoral growth is also considered an irreversible change. Fat redistribution and increased muscle mass are generally considered reversible effects, but some degree of redistribution may be irreversible. The cessation of monthly bleeding is generally achievable within the first 3–6 months of GAHT. 

 

Fertility is decreased during testosterone administration, but should not be relied upon as contraception. While there may be an irreversible reduction in fertility, many patients with a capacity to become pregnant have conceived healthy pregnancies following the discontinuation of testosterone (see Fertility and Birth Control section).

        

Typically, patients taking testosterone will experience associated changes over a period of months to years. The timeframe of physiological changes may be slightly slower with the use of transdermal preparations. The degree and rate of physical effects are also dependent on the dose administered, as well as patient-specific factors such as age, ethnicity, genetics, body habitus and lifestyle. The effects of testosterone and their expected time courses are shown below.

If cessation of monthly bleeding is not achieved within the first 6 months of GAHT, testosterone dosage may need to be increased if not already at a maximum dose. In patients who prefer low-dose testosterone, or occasionally in patients using transdermal preparations, a progestin may be used, either in the form of a levonorgestrel-releasing intrauterine system (IUS) (e.g., “Mirena”), or an injectable medroxyprogesterone acetate (MPA) (e.g., “Depo-Provera”). Alternatively, a GnRH analogue (leuprolide/“Lupron” or busrelin/“Suprefact”) can be used to suppress monthly bleeding and the expression of endogenous estrogen-based hormones. 

All patients with child-bearing potential (i.e., uterus and ova) who are considering testosterone should be counselled regarding its teratogenic impact (specifically hyper-androgenization of the fetus), regardless of current sexual practices. Patients should be aware of their ongoing risk of pregnancy, despite testosterone therapy or amenorrhea. It is important not to make assumptions about the type of sex a patient is having or may have. If a patient with child-bearing potential is having receptive penetrative genital sex with a partner who makes sperm, an effective method of birth control should be employed (see Part 6: Sexual Health and Reproduction of this document).

If unintended pregnancy does occur while on testosterone, patients should be counselled regarding their options, and testosterone therapy should be discontinued immediately if maintaining the pregnancy is desired or under consideration.    

Application Tips

Injection

  • Testosterone cypionate is compounded in cottonseed oil, while testosterone enanthate is compounded in sesame oil, making both formulations non-irritating but quite viscous.

  • Warming the vial in the palm of the hand for a few moments will reduce viscosity.

  • Generally, testosterone is drawn up with larger-gauge needles (18–20G) and then injected intramuscularly with medium- gauge needles (22–23G) or subcutaneously with smaller-gauge needles (25–26G). This can be adjusted to manage patient discomfort as needed—smaller gauge needles may mean longer injections, but less pain.

  • Needle lengths are determined by body habitus and route of administration.

  • The use of a 1 ml syringe can improve accuracy when drawing up smaller doses of injectable testosterone and will decrease the force required to press the plunger of the syringe upon injection, compared to a 3 ml syringe. 

 

Gel 

  • Gel should be applied to the upper arms, shoulders and/or abdomen (the axillary gel formulation AxironTM is unfortunately no longer being manufactured).

  • If a gel formulation is used, patients should be counselled regarding the risk of inadvertent exposure to others who come into contact with the patient’s skin. This is of particular importance for patients who care for young children and/or have intimate partners who are pregnant or considering pregnancy. 

  • Testosterone gel should be allowed to dry prior to getting dressed, and the site of application should remain dry for at least two hours (to allow for absorption into the dermis). 

  • Thorough hand washing should be performed following application, and gloves worn if the gel is applied by someone else. 

 

Patch

  • Patches should be applied to a flat, clean, dry and undamaged area of skin on the back, stomach, upper arm or thigh. 

Effects and Expected Time Course of Testosterone-Based Hormone Regime 

Effects and expected time course of masculinizing hormones .png

In New Brunswick, options for testosterone administration include injectable and transdermal preparations (patch or gel). Injectable formulations are most commonly used, due to superior efficacy and affordability. Injectable, patch, and gel forms of testosterone are funded by the NB Drug Plan with premiums based on annual income. The NB Drug Plan is available to NB residents who have an active Medicare card and meet one of the following criteria:

  • Do not have existing drug coverage through a private plan or other government program, or

  • Have existing drug coverage with a private plan, however:

    • They have reached the annual or lifetime maximum for drug coverage with the private plan, or

    • They have been prescribed a drug that is not listed on their private plan formulary for the condition (indication) prescribed. (Prior to applying, contact the New Brunswick Drug Plan Information Line toll free at 1-855-540-7325 to confirm that the requested drug is included in the New Brunswick Drug Plan Formulary).

 

2SQTP-NB/P2SQT-NB recommends that PCPs ensure that patients are informed about the NB Drug Plan and direct them towards this form.

 

Additionally, patients may be able to access funding through the Non-Insured Health Benefits Program (NIHB) for Status First Nation clients,  and by the The New Brunswick Prescription Drug Program (NBPDP) depending on patient eligibility. For more information, see NIHB Program.

 

Transdermal preparations provide a more relatively steady state of testosterone delivery, as opposed to the periodicity associated with injectables. However, some 2STIGD folks using transdermal preparation have noted experiencing local reactions, higher cost, fear of skin-to-skin transmission, problems with the adhesion of patches, inconvenience of gel application time, and an unpleasant odor with gel.    

 

While intramuscular injection is the most common means of administering parenteral testosterone, subcutaneous (SC) delivery has also been used with clinical efficacy and is very well tolerated. While the IM route remains better studied and often more familiar to both patients and providers, we feel that enough evidence exists to suggest reasonable safety and efficacy for the SC route and so are comfortable offering this as an option for our patients.    PCPs should work collaboratively with their patients to determine which method of testosterone-based GAHT is right for them.    

 

If patients want to self-inject, it is important to instruct them on techniques for safe injection and sharps disposal. Directly observing a patient self-inject is helpful for the correction of any problems with technique and to reassure patients that they are injecting correctly. Ideally patients would complete their first hormone administration in a PCP’s office. A written step-by-step guide on self-injection for patients is here. Additionally, it may be helpful to have patients record the injection training on their phone to refer to after.            

Dosage

Price quotes provided by APSI, accurate as of August 2022 and represent the price of the generic brand of medication unless otherwise indicated (ranging from low dose to maximum dose). Prices reflect the actual customer cost for purchase within New Brunswick, including a dispensing fee, and not including Medicare or a drug plan.           

 

Note: Testosterone (in all forms) is considered a controlled substance in Canada; prescriptions should be written in accordance with provincial requirements for controlled substances. 

Testim 1%

Prescription 

Testim 1% (transdermal gel)

Starting Dose / Low Dose

2.5–5g daily (2–4 pumps, equivalent to 25– 50 mg testosterone)

Maximum Dose

5–10 g daily (4–8 pumps, equivalent to 50–100 mg testosterone) 

Purchasing Cost

(50 x 5g) = $161.10 per unit

$45.11-180.43 every 4 weeks

Monitoring and Dose Adjustments (Testosterone-Based GAHT)

Titration of doses will generally occur in the early phases of GAHT. For example, with injectable testosterone, a starting dose of 30 mg injected weekly could be increased by 10–20 mg every 4 to 6 weeks. Speed of titration will depend on lab results, patient goals, and side effects.

 

Some patients will intentionally seek testosterone levels midway between the male and female range. For patients seeking the maximum effects of testosterone, the target dose will bring the testosterone level into the physiologic male range. It is important to keep in mind, however, that clinical effects are the goal of therapy, not specific lab values. If a patient is happy with the rate and degree of masculinization, there is no need to increase the dose to achieve a certain range. Alternatively, if levels are at the lower end of the male range and patients are concerned about slow progress, or low energy, libido, mood or breakthrough bleeding, the dose can be slowly increased with close monitoring. 

 

Monitoring should be done at 3, 6 and 12 months after starting therapy. Some PCPs may also prefer to see patients monthly until an effective dose is established. After the first year of GAHT, hormone levels can be monitored yearly in the absence of metabolic shifts such as substantial weight gain, concerns regarding regression of virilization, or the emergence of symptoms potentially related to hormone levels (e.g., cyclic symptoms such as migraines or pelvic cramping/bleeding).

 

Follow-up visits should include a functional inquiry, a targeted physical exam, bloodwork, and health promotion and disease prevention counselling. The suggested tasks for each of these follow-up visits are as follows:

Review

  • Contraindications and precautions to testosterone 

  • Education/Lifestyle 

  • Health Maintenance

  • Old records

  • Mental Health

  • Psychosocial

Lab

  • BP

  • Focused PE with PAP if indicated

  • Height

  • Weight

Exam

  • Pregnancy test prior to 1st dose

Other

  • Consider HPV, Hep A, B and routine vaccinations as indicated

Functional inquiry should include noted positive or negative impacts on overall well-being, mood/mental health, and energy levels (including fluctuation). It is useful to inquire about how the patient is managing any changes in libido. Inquiry regarding physiological changes should include discussion of monthly bleeding. There may be some irregular bleeding or spotting in the first few months of treatment. However, once sustained cessation is achieved, any bleeding without explanation (e.g., missed dose(s) or lowered dose of testosterone) warrants a workup for endometrial hyperplasia or cancer.

 

When monitoring injectable testosterone, some clinicians prefer to check serum levels at trough (i.e., just before the next injection is due) while others prefer mid-cycle. The former adds convenience for patients who prefer to come into the clinic for their injections. There may be utility in varying the timing of bloodwork to gather information regarding serum levels throughout the cycle (peak, mid-cycle and trough), especially if a patient is reporting cyclic symptoms or breakthrough bleeding. In such cases, wide fluctuations should prompt consideration of increasing the frequency of injections or switching to a route with less periodicity.

 

Supraphysiologic levels should be avoided due to the increased risk of adverse events and side effects, as well as the potential for the aromatization of excess testosterone into estrogen. Dose adjustment is warranted if supraphysiologic doses are measured at mid-cycle or trough. Since changes to the integument occur with testosterone administration, patients on a transdermal formulation may require ongoing titration in order to obtain or maintain physiologic changes. 

 

If the sex marker associated with the patient’s health card has not been changed, the reference ranges reported from the laboratory will refer to the sex assigned at birth. Reference ranges vary between laboratories, so it is important to refer to reference ranges for the affirmed gender from the laboratory. It is advised to indicate AMAB or AFAB to reduce likelihood of sample rejection. Blood work should be completed according to the table below:

Recommended blood work for monitoring testosterone-based GAHT        

In this table, smaller and lighter grey “x”s indicate parameters that are measured under particular circumstances

Recommended blood work for monitoring testosterone-based GAHT.png

There is little information in the literature to guide recommendations for the initiation or maintenance of testosterone-based GAHT in older or aging patients. Unique considerations in older populations include changes in endogenous hormone levels; physiologic changes that may affect response to medications; a higher burden of existing medical conditions; and multiple concurrent medications leading to the increased potential for drug interactions.    


As patients age, dose reductions can be discussed and considered in accordance with patients’ goals. Some guidelines suggest considering complete discontinuation for patients over 50, however those without gonads may experience symptoms of hypogonadism, along with potential bone mineral density loss. Those with or without gonads may be expected to experience reduced muscle mass, body hair and libido, though in some cases the irreversible changes induced by testosterone may be sufficient to maintain a presentation that is consistent with a patient’s needs. As with all patients, decisions about GAHT at an advanced age should be individualized, following a thorough discussion of risks and benefits.

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Providers may have concerns about the safety of testosterone, particularly with respect to metabolic impacts, cardiovascular (CV) events, and malignancies. Pre-existing medical conditions and risk factors may impart increased risks with testosterone administration and should be considered in order to enable individualized discussions with patients regarding the risks and benefits of treatment. Measures available to reduce associated risks should be considered and discussed with patients, and, if possible, undertaken prior to or concurrently with the initiation of GAHT. 

 

In some cases, patients may wish to begin GAHT in the setting of ongoing increased risk, e.g., immitigable risk or having declined measures for risk mitigation. In such situations, a careful informed consent process should be followed which takes into consideration: individual capacity to make an informed decision, the severity of potential harms from treatment, and the harms that may result from not treating.

 

Initiating testosterone should ideally be done in collaboration with relevant specialists who may already be involved in a patient’s care. In some cases, a new referral may be helpful in informing decisions about risks and their mitigation. However, efforts should be taken to ensure that this does not cause undue delay. If access to a specialist is limited, an e-consult can be both timely and beneficial. 

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The long-term follow-up of patients on testosterone-based GAHT should involve (at least) annual preventive care visits. Preventive Care Checklists© endorsed by the College of Family Physicians of Canada exist for cisgender patients; however, the use of these forms for 2STIGD patients is awkward, unaffirming, and can lead to missed elements important in their comprehensive primary care. 2SQTP-NB/P2SQT-NB has assembled recommendations from Sherbourne Health and Rainbow Health into an adapted Preventive Care Checklist for the ongoing primary care of patients on testosterone-based hormone therapy. The use of these gender-specific forms assumes familiarity with the standard forms and their explanations. The recommendations represent an effort to incorporate expert opinion, relevant research on cisgender populations and limited gender-specific evidence, with standard national and provincial primary care practices. 

Precautions with testosterone-based GAHT and minimizing associated risks

  • Refer to neurology

BP: blood pressure; 

CPAP: continuous positive airway pressure; 

DVT: deep vein thrombosis; 

IBD: irritable bowel disease; 

MS: multiple sclerosis; 

NAFLD: non-alcoholic fatty liver disease; 

NRT: nicotine replacement therapy; 

PCOS: ​​polycystic ovary syndrome; 

PE: pulmonary embolus; 

RA: rheumatoid arthritis

For more information on the specific conditions associated with testosterone-based GAHT, risk mitigation, and long-term preventive care, see Sherbourne’s guidelines for gender-affirming primary care with trans and non-binary patients. These guidelines include information and research on the following:

  • Acne

  • Atrophic changes

  • Breast cancer            

  • Cardiovascular disease and related metabolic risk factors        

  • Cervical cancer and Pap tests            

  • Hair loss                    

  • Hepatic dysfunction        

  • Human immunodeficiency virus (HIV) 

  • Obstructive sleep apnea                    

  • Osteoporosis and bone mineral density screening                

  • Ovarian cancer                

  • Pelvic pain                

  • Polycythemia                

  • Psychiatric effects            

  • Vaginal bleeding and endometrial cancer        

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