Masculinizing hormone therapy explained

Masculinizing hormone therapy, also known as transmasculine hormone therapy or female-to-male (or FTM) hormone therapy, is a form of hormone therapy and gender affirming therapy which is used to change the secondary sexual characteristics of transgender people from feminine or androgynous to masculine.[1] [2] [3] It is a common type of transgender hormone therapy (another being feminizing hormone therapy), and is predominantly used to treat transgender men and other transmasculine individuals who were assigned female at birth. Some intersex people also receive this form of therapy, either starting in childhood to confirm the assigned sex or later if the assignment proves to be incorrect.

The purpose of this form of therapy is to cause the development of the secondary sex characteristics of the desired sex, such as voice deepening and a masculine pattern of hair, fat, and muscle distribution. It cannot undo many of the changes produced by naturally occurring puberty, which may necessitate surgery and other treatments to reverse. The medications used for FTM therapy include, mainly, androgens (namely testosterone) and GnRH analogues.

While the therapy cannot undo the effects of a person's first puberty, developing secondary sex characteristics associated with a different sex can relieve some or all of the distress and discomfort associated with gender dysphoria, and can help the person to "pass" or be seen as their gender identity. Introducing exogenous (not internally produced) hormones into the body impacts it at every level and many patients report changes in energy levels, mood, appetite, etc. The goal of the therapy, and indeed all somatic treatments, is to provide patients with a more satisfying body that is more congruent with their gender identity.

Masculinizing hormone therapy has been shown to likely reduce the distress and discomfort associated with gender dysphoria.[4]

Medical uses

Testosterone replacement therapy (TRT)
  • Utilized to address hypogonadism or low testosterone levels in assigned female at birth (AFAB) individuals, fostering the development of masculine secondary sexual characteristics.
    Gender affirmation in transgender men
  • Administered as part of gender transition to align the physical appearance with the affirmed gender, inducing changes such as facial hair growth and deepening of the voice.
    Puberty suppression in gender diverse youth
  • In certain cases, hormonal interventions are employed to delay puberty, offering individuals more time to explore their gender identity before undergoing permanent physical changes.

    These medical uses of masculinizing hormone therapy are subject to individual health considerations and are typically administered under the supervision of healthcare professionals.[5]

    History

    See main article: Transgender history.

    Contraindications

    Several contraindications to androgen therapy exist.[6] An absolute medical contraindication is pregnancy.

    Relative medical contraindications are:

    Safety

    Due to insufficient comprehensive research, there is no consensus on the full range of risks of lengthy testosterone administration, especially as it is difficult to achieve a sufficient number of participants for results to be meaningful.Two 2019 studies indicate the potential for elevated risk of cardiovascular events. One study found that transgender men taking testosterone had an increased risk of cardiovascular events compared to cisgender women, with 11 vs. 3 cardiovascular events per 100,000 person-years, though the risk was less than that of cisgender men. Researchers were not able to control for smoking status or stressors.[7] The other study found elevated risk of heart attacks among self-identified transgender men—which persisted even after adjusting for age, diabetes mellitus, chronic kidney disease, smoking, hypertension, hypercholesterolemia, and exercise—though the study did not include data about whether the subjects were undergoing hormone therapy and did not control for stressors. The study found that transgender men have a >4-fold and 2-fold increased odds of having a myocardial infarction when compared with cisgender women and cisgender men, respectively.[8] Though it is not always the case,[2] [9] testosterone for transmasculine people is often intended to be used long-term.

    A 2022 review entitled The efficacy, safety, and outcomes of testosterone use among transgender men patients: A review of the literature,[10] while pointing out that more research is needed for newer therapies, concludes that:

    Interactions

    Testosterone is metabolized by the cytochrome P450 enzyme system (specifically CYP3A isoforms) in the liver. There are certain drugs that increase or decrease the activity of cytochrome P450 enzymes and may cause increased or decreased levels of testosterone:

    Testosterone can also alter the effects of other drugs:

    Because of these interactions, it is advised that trans men make their healthcare providers aware of their hormone therapy when this is relevant to their treatment for other medical issues.

    Medications

    Medications used in hormone therapy for transgender men include androgens and anabolic steroids like testosterone (by injection and other routes) to produce masculinization, suppress estrogen and progesterone levels, and prevent/reverse feminization; GnRH agonists and antagonists to suppress estrogen and progesterone levels; progestins like medroxyprogesterone acetate to suppress menses; and 5α-reductase inhibitors to prevent/reverse scalp hair loss.

    Testosterone

    The elimination half-life of testosterone in the blood is about 70 minutes, so it is necessary to have a continuous supply of the hormone for masculinization.

    A study of 45 FtM individuals randomly assigned to receive testoviron depot (intramuscular, 100 mg/10 days), testosterone gel (50 mg/day), or testosterone undecanoate (intramuscular, 1000 mg) found increased lean body mass, decreased fat mass, decreased high-density plasma lipoprotein levels, increased low-density lipoprotein levels, and increased prothrombin time. No differences were found between the different formulations of testosterone, and at week 54 all subjects were amenorrheic (no longer experiencing menstrual periods).

    1 year after treatment, general life satisfaction was increased in all subjects.[11]

    Injected

    'Depot' drug formulations are created by mixing a substance with the drug that slows its release and prolongs the action of the drug. The two primarily used forms in the United States are the testosterone esters testosterone cypionate (Depo-Testosterone) and testosterone enanthate (Delatestryl or Xyosted) which are almost interchangeable. Testosterone enanthate is purported to be slightly better with respect to even testosterone release, but this is probably more of a concern for bodybuilders who use the drugs at higher doses (250–1000 mg/week) than the replacement doses used by transgender men (50–100 mg/week). These testosterone esters are mixed with different oils, so some individuals may tolerate one better than the other. Testosterone enanthate costs more than testosterone cypionate and is more typically the one prescribed for hypogonadal males in the US. Testosterone cypionate is more popular in the US than elsewhere (especially amongst bodybuilders). Other formulations exist but are more difficult to come by in the US. A formulation of injected testosterone available in Europe and the US, testosterone undecanoate (Nebido, Aveed)[12] [13] provides significantly improved testosterone delivery with far less variation outside the eugonadal range than other formulations with injections required only four times yearly. However, each quarterly dose requires an injection of 4 mL of oil which may require multiple simultaneous injections. Testosterone undecanoate is also much more expensive as it is still under patent protection. Testosterone propionate is another testosterone ester that is widely available, including in the US, Canada, and Europe, but it is very short-acting compared to the other testosterone esters and must be administered once every 2 or 3 days, and for this reason, is rarely used.

    The adverse side effects of injected testosterone esters are generally associated with high peak levels in the first few days after an injection. Some side effects may be ameliorated by using a shorter dosing interval (weekly or every ten days instead of twice monthly with testosterone enanthate or testosterone cypionate). 100 mg weekly gives a much lower peak level of testosterone than does 200 mg every two weeks, while still maintaining the same total dose of androgen. This benefit must be weighed against the discomfort and inconvenience of doubling the number of injections.

    Injectable forms of testosterone can cause a lung problem called pulmonary oil microembolism (POME). Symptoms of POME include cough, shortness of breath, tightening of the throat, chest pain, sweating, dizziness, and fainting.[14] [15] A postmarketing analysis by the manufacturer of Aveed (testosterone undeconate injection) found that POME occurred at a rate of less than 1% per injection per year for Aveed.[16]

    Injected testosterone esters should be started at a low dose and titrated upwards based on trough levels (blood levels drawn just before your next shot). A trough level of 500 ng/dL is sought. (Normal range for a cisgender man is 290 to 900 ng/dL).

    Transdermal

    Testosterone patches, creams, and gels are available. Both approximate normal physiological levels of testosterone better than the higher peaks associated with injection. Both can cause local skin irritation (more so with the patches).

    Patches slowly diffuse testosterone through the skin and are replaced daily. The cost varies, as with all medication, from country to country, it is about $150/month in the US, and about €60 in Germany. Transdermal testosterone has the advantage of delivering a consistent supply of hormones over a given period and having a simple method of diffusion.[17]

    Transdermal testosterone is available throughout the world under the brand names Andromen Forte, Androgel, Testogel and Testim. They are absorbed quickly when applied and produce a temporary drug depot in the skin which diffuses into the circulation, peaking at 4 hours and decreasing slowly over the rest of the day. The cost varies, as with all medication, from country to country, from as little as $50/month to about $280/month.

    Transdermal testosterone poses a risk of inadvertent exposure to others who come in contact with the patient's skin. This is most important for patients whose intimate partners are pregnant or those who are parents of young children as both of these groups are more vulnerable to the masculinizing effects of androgens. Case reports of significant virilization of young children after exposure to topical androgen preparations (both prescription and 'supplement' products) used by their caregivers demonstrates this very real risk, the same principle also applies to estrogens.[18]

    Implants

    Implants, as subcutaneous pellets, can be used to deliver testosterone (brand name Testopel). 6 to 12 pellets are inserted under the skin every three months. This must be done in a physician's office, but is a relatively minor procedure done under local anesthetic. Pellets cost about $60 each, so the cost is greater than injected testosterone when the cost of the physician visit and procedure are included. The primary advantages of Testopel are that it gives a much more constant blood level of testosterone yet requires attention only four times yearly.

    Oral

    Oral testosterone is provided exclusively as testosterone undecanoate. It is available in Europe and Canada, but not in the US. Once absorbed from the gastrointestinal tract, testosterone is shunted (at very high blood levels) to the liver where it can cause liver damage (albeit very rarely) and worsens some of the adverse effects of testosterone, like lower HDL cholesterol. In addition, the first-pass metabolism of the liver also may result in testosterone levels too low to provide satisfactory masculinization and suppress menses. Because of the short terminal half-life of testosterone, oral testosterone undecanoate must be administered two to four times per day, preferably with food (which improves its absorption).

    Sublingual and buccal

    In 2003, the FDA approved a buccal form of testosterone (Striant). Sublingual testosterone can also be made by some compounding pharmacies. Cost for Striant is greater than other formulations (/month). Testosterone is absorbed through the oral mucosa and avoids the first-pass metabolism in the liver which is the cause of many of the adverse effects of oral testosterone undecanoate. The lozenges can cause gum irritation, taste changes, and headache but most side effects diminish after two weeks. The lozenge is 'mucoadhesive' and must be applied twice daily.

    Alternative androgens

    Synthetic androgens

    Synthetic androgens/anabolic steroids (AAS), like nandrolone (as an ester like nandrolone decanoate or nandrolone phenylpropionate), are agonists of the androgen receptor (AR) similarly to testosterone but are not usually used in HRT for transgender men or for androgen replacement therapy (ART) in cisgender men. However, they can be used in place of testosterone with similar effects, and can have certain advantages like less or no local potentiation in so-called androgenic tissues that express 5α-reductase like the skin and hair follicles (which results in a reduced rate of skin and hair-related side effects like excessive body hair growth and scalp hair loss), although this can also be disadvantageous in certain aspects of masculinization like facial hair growth and normal body hair growth). Although many AAS are not potentiated in androgenic tissues, they have similar effects to testosterone in other tissues like bone, muscle, fat, and the voice box. Also, many AAS, like nandrolone esters, are aromatized into estrogens to a greatly reduced extent relative to testosterone or not at all, and for this reason, are associated with reduced or no estrogenic effects (e.g., gynecomastia). AAS that are 17α-alkylated like methyltestosterone, oxandrolone, and stanozolol are orally active but carry a high risk of liver damage, whereas AAS that are not 17α-alkylated, like nandrolone esters, must be administered by intramuscular injection (via which they act as long-lasting depots similarly to testosterone esters) but have no more risk of liver damage than does testosterone.

    For the sake of clarification, the term "anabolic–androgenic steroid" is essentially synonymous with "androgen" (or with "anabolic steroid"), and that natural androgens like testosterone are also AAS. These drugs all share the same core mechanism of action of acting as agonists of the AR and have similar effects, although their potency, pharmacokinetics, oral activity, ratio of anabolic to androgenic effects (due to differing capacities to be locally metabolized and potentiated by 5α-reductase), capacity for aromatization (i.e., conversion into an estrogen), and potential for liver damage may all differ.

    Dihydrotestosterone

    Dihydrotestosterone (DHT) (referred to as androstanolone or stanolone when used medically) can also be used in place of testosterone as an androgen. The availability of DHT is limited; it is not available in the United States or Canada, for instance, but it is available in certain European countries, including the United Kingdom, France, Spain, Belgium, Italy, and Luxembourg.[19] DHT is available in formulations including topical gel, buccal or sublingual tablets, and as esters in oil for intramuscular injection.[20] Relative to testosterone, and similarly to many synthetic AAS, DHT has the potential advantages of not being locally potentiated in so-called androgenic tissues that express 5α-reductase (as DHT is already 5α-reduced) and of not being aromatized into an estrogen (it is not a substrate for aromatase).

    DHT is common androgen used by intersex men to initiate the development of masculine secondary sex characteristics, particularly for individuals with partial androgen insensitivity syndrome (who are often assigned female at birth). As the masculinizing effects of testosterone is limited in AIS, DHT more easily binds to androgen receptors and cannot be directly converted into estrogen via the androgen backdoor pathway, this is useful as an androgen treatment for AIS as testosterone can often result in unintentional feminizing effects such as breast growth and hip widening. DHT can be converted into testosterone which can be aromatased into estrogen however this is low.[21] [22]

    Gonadotropin-releasing hormone modulator analogues

    In all people, the hypothalamus releases gonadotropin-releasing hormone (GnRH) to stimulate the pituitary to produce luteinizing hormone (LH) and follicle-stimulating hormone (FSH) which in turn cause the gonads to produce sex steroids.

    In adolescents, GnRH analogues such as leuprorelin can be used to suspend the advance of sex steroid induced, inappropriate pubertal changes for a period without inducing any changes in the gender-appropriate direction. GnRH analogues work by initially overstimulating the pituitary gland then rapidly desensitizing it to the effects of GnRH. Over a period of weeks, gonadal androgen production is greatly reduced.

    The WPATH permits GnRH from Tanner stage 2. The sex steroids do have important other functions. The high cost of GnRH analogues is often a significant factor.

    Antiestrogens

    Antiestrogens (or so-called "estrogen blockers") like aromatase inhibitors (AIs) (e.g., anastrozole) or selective estrogen receptor modulators (SERMs) (e.g., tamoxifen) can be used to reduce the effects of high levels of endogenous estrogen (e.g., breast development, feminine fat distribution) in transgender men. In addition, in those who have not yet undergone or completed epiphyseal closure (which occurs during adolescence and is mediated by estrogen), antiestrogens can prevent hip widening as well as increase final height (estrogen limits height by causing the epiphyses to fuse).

    Others

    5α-Reductase inhibitors

    5α-Reductase inhibitors like finasteride and dutasteride can be used to slow or prevent scalp hair loss and excessive body hair growth in transgender men taking testosterone.[23] However, they may also slow or reduce certain aspects of masculinization, such as facial hair growth, normal male-pattern body hair growth, and possibly clitoral enlargement.[24] A potential solution is to start taking a 5α-reductase inhibitor after these desired aspects of masculinization have been well-established.

    Progestogens

    Progestogens can be used to control menstruation in transgender men. Depot medroxyprogesterone acetate (DMPA) may be injected every three months just as it is used for contraception. Generally after the first cycle, menses are greatly reduced or eliminated. This may be useful for transgender men prior to initiation of testosterone therapy.

    Growth hormone

    In those who have not yet started or completed epiphyseal closure, growth hormone can be administered, potentially in conjunction with an aromatase inhibitor or a GnRH analogue, to increase final height.

    Effects

    The main effects of testosterone in trans men are as follows:[25]

    Reversible changes
    Irreversible changes

    Physical changes

    Skin changes

    Hair changes

    Facial changes

    Facial changes develop gradually over time, and sexual dimorphism (physical difference between the sexes) tends to increase with age. Within a population of similar body size and ethnicity:

    Endocrine and gynecological changes

    Frequently the first sign of endometrial cancer is bleeding in post-menopausal women. Transgender men who have any bleeding after the cessation of menses with androgen therapy should be evaluated for age appropriate causes of abnormal uterine bleeding as per cisgender female guidelines.[27]

    Reproductive changes

    Neurological changes

    Psychological changes

    The psychological changes are harder to define, since HRT is usually the first physical action that takes place when transitioning. This fact alone has a significant psychological impact, which is hard to distinguish from hormonally induced changes. Most trans men report an increase of energy and an increased sex drive. Many also report feeling more confident.

    While a high level of testosterone is often associated with an increase in aggression, this is not a noticeable effect in most trans men. HRT doses of testosterone are much lower than the typical doses taken by steroid-using athletes, and create testosterone levels comparable to those of most cisgender men. These levels of testosterone have not been proven to cause more aggression than comparable levels of estrogen.

    Some transgender men report mood swings, increased anger, and increased aggressiveness after starting androgen therapy. Studies are limited and small scale, however, based on self reporting over a short period of time (7 months). In a study by Motta et al., trans men also reported better anger control.[32] Many transgender men, however, report improved mood, decreased emotional lability, and a lessening of anger and aggression.[33]

    A randomized clinical trial on the effects of testosterone therapy in a group of transgender and gender expansive adults found that the group given treatment had significantly reduced dysphoria, depression, and suicidality relative to the control group.[34]

    Health-related changes

    Cardiovascular changes

    Gastrointestinal changes

    Metabolic changes

    Bone changes

    Obstructive sleep apnea

    See main article: Sleep apnea.

    Polycythemia

    See main article: Polycythemia.

    Hormone levels

    During HRT, especially in the early stages of treatment, blood tests should be consistently done to assess hormone levels and liver function.

    Gianna Israel and colleagues have suggested that for pre-oophorectomy trans men, therapeutic testosterone levels should optimally fall within the normal male range, whereas estrogen levels should optimally fall within the normal female range. Before oophorectomy, it is difficult and frequently impractical to fully suppress estrogen levels into the normal male range, especially with exogenous testosterone aromatizing into estrogen, hence why the female ranges are referenced instead. In post-oophorectomy trans men, Israel and colleagues recommend that both testosterone and estrogen levels fall exactly within the normal male ranges. See the table below for all of the precise values they suggest.[39]

    HormoneCis female rangeCis male rangeOptimal trans female rangeOptimal trans male range
    Estrogen (total)40–450 pg/mL< 40 pg/mL400–800 pg/mL (pre-orchiectomy)
    40–400 pg/mL (post-orchiectomy)    		< 400 pg/mL (pre-oophorectomy)
    < 40 pg/mL (post-oophorectomy)
    Testosterone (total)25–95 ng/dL225–900 ng/dL95–225 ng/dL (pre-orchiectomy)
    25–95 ng/dL (post-orchiectomy)    		225–900 ng/dL (pre-oophorectomy)
    225–900 ng/dL (post-oophorectomy)

    The optimal ranges listed for testosterone only apply to individuals taking bioidentical hormones in the form of testosterone (including esters) and do not apply to those taking synthetic AAS (e.g., nandrolone) or dihydrotestosterone.

    See also

    External links

    Notes and References

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    2. Unger CA . Hormone therapy for transgender patients . Translational Andrology and Urology . 5 . 6 . 877–884 . December 2016 . 28078219 . 5182227 . 10.21037/tau.2016.09.04 . free .
    3. Web site: Masculinizing hormone therapy - Mayo Clinic . 2022-09-27 . www.mayoclinic.org.
    4. van Leerdam TR . Zajac JD . Cheung AS . Ada Cheung . The Effect of Gender-Affirming Hormones on Gender Dysphoria, Quality of Life, and Psychological Functioning in Transgender Individuals: A Systematic Review . Transgender Health . 8 . 1 . 6–21 . February 2023 . 36895312 . 9991433 . 10.1089/trgh.2020.0094 . 239635388 .
    5. Web site: Masculinizing Hormone Therapy . 17 February 2022 .
    6. Hembree WC, Cohen-Kettenis P, Delemarre-van de Waal HA, Gooren LJ, Meyer WJ, Spack NP, Tangpricha V, Montori VM . 6 . Endocrine treatment of transsexual persons: an Endocrine Society clinical practice guideline . The Journal of Clinical Endocrinology and Metabolism . 94 . 9 . 3132–3154 . September 2009 . 19509099 . 10.1210/jc.2009-0345 . 20486653 . free . Endocrine Society .
    7. Nota NM, Wiepjes CM, de Blok CJ, Gooren LJ, Kreukels BP, den Heijer M . Occurrence of Acute Cardiovascular Events in Transgender Individuals Receiving Hormone Therapy . Circulation . 139 . 11 . 1461–1462 . March 2019 . 30776252 . 10.1161/CIRCULATIONAHA.118.038584 . free .
    8. Alzahrani T, Nguyen T, Ryan A, Dwairy A, McCaffrey J, Yunus R, Forgione J, Krepp J, Nagy C, Mazhari R, Reiner J . 6 . Cardiovascular Disease Risk Factors and Myocardial Infarction in the Transgender Population . Circulation: Cardiovascular Quality and Outcomes . 12 . 4 . e005597 . April 2019 . 30950651 . 10.1161/CIRCOUTCOMES.119.005597 . free .
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    16. Pastuszak AW, Hu Y, Freid JD . Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis . Sexual Medicine . 8 . 2 . 237–242 . June 2020 . 32184081 . 7261689 . 10.1016/j.esxm.2020.01.009 . free .
    17. Web site: Overview of masculinizing hormone therapy | Gender Affirming Health Program. transcare.ucsf.edu.
    18. Prenatal Virilization Associated with Paternal Testosterone Gel Therapy. Patel A, Rivkees SA . International Journal of Pediatric Endocrinology . 2010 . 2010 . 1–4 . 10.1155/2010/867471 . 20976267 . 2952944 . free .
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    21. Web site: Topical dihydrotestosterone to treat micropenis secondary to partial androgen insensitivity syndrome (PAIS) before, during, and after puberty - A case series | Request PDF.
    22. Web site: Partial Androgen Insensitivity Syndrome (PAIS) | Intersex Society of North America. isna.org.
    23. Ginsberg BA . Dermatologic care of the transgender patient . International Journal of Women's Dermatology . 3 . 1 . 65–67 . March 2017 . 28492057 . 5418958 . 10.1016/j.ijwd.2016.11.007 . In addition, oral finasteride may block the development of wanted secondary physical features, including voice change, body hair and composition, and clitoromegaly. Therefore, it is important to ensure that all desired changes are complete before the initiation of treatment with finasteride, which is frequently after 2 years of testosterone use. .
    24. Irwig MS . Is there a role for 5α-reductase inhibitors in transgender individuals? . Andrology . 9 . 6 . 1729–1731 . November 2021 . 32749751 . 10.1111/andr.12881 . 225308605 . free .
    25. Web site: Standards of Care, Version 7. WPATH. December 13, 2016. dead. https://web.archive.org/web/20140128104021/http://www.wpath.org/site_page.cfm?pk_association_webpage_menu=1351&pk_association_webpage=3926. January 28, 2014.
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    27. Grimstad FW, Fowler KG, New EP, Ferrando CA, Pollard RR, Chapman G, Gomez-Lobo V, Gray M . 6 . Uterine pathology in transmasculine persons on testosterone: a retrospective multicenter case series . American Journal of Obstetrics and Gynecology . 220 . 3 . 257.e1–257.e7 . March 2019 . 30579875 . 10.1016/j.ajog.2018.12.021 . 58556160 .
    28. Anderson . William J. . Kolin . David L. . Neville . Grace . Diamond . David A. . Crum . Christopher P. . Hirsch . Michelle S. . Vargas . Sara O. . August 2020 . Prostatic Metaplasia of the Vagina and Uterine Cervix: An Androgen-associated Glandular Lesion of Surface Squamous Epithelium . The American Journal of Surgical Pathology . 44 . 8 . 1040–1049 . 10.1097/PAS.0000000000001486 . 1532-0979 . 32282346. 215759984 .
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