Annex A, Standards of Care in the Treatment of 
Gender Dysphoria & Transsexualism

ANNEX A [1]

STANDARDS of CARE GUIDELINES for GPs

General Notes for Treatment of Trans Women & Trans Men

Gender dysphoric and trans people may present for treatment for their gender dysphoric condition, and also for totally unrelated conditions. Whatever their needs, they must be addressed and accommodated according to their core gender identity, unless they specify otherwise. If medical and/or administrative staff are unsure of how to address an individual, Mr, Miss, Ms, Mrs, it is better to ask The terms trans woman (male to female individual) and trans man (female to male individual) are used, in accordance with the preference of the trans communities.

The diagnosis of Gender Dysphoria may be made by the GP, together with the patient concerned, when he or she expresses some level of inconsistency between the psychological identification as male or female, and the phenotype. This diagnosis may be confirmed, again, in conjunction with the patient, by a specialist Psychiatrist, to whom the GP may make a referral. This specialist may indicate that co-existing conditions or illnesses may need prior, or parallel, treatment. Many individuals will describe having been aware of symptoms of discomfort with their assigned gender, starting in childhood and becoming progressively more intrusive. Generally speaking, where the inconsistency between phenotype and gender identification has resulted in a profound and persistent discomfort, over a period of approximately two years or more, the individual may be diagnosed as experiencing transsexualism, so there may be a medical need to transition to the opposite phenotype and gender role from that in which the individual has lived up to this point. Throughout, treatment should be flexible and patient led, as far as is consistent with clinical safety. The practitioner should take full account of the individual’s view of his or her needs and also his or her view on the scheduling of treatment. Many social, employment and family pressures create dilemmas which can influence and change the treatment and its scheduling, before a final course of action is determined. Different levels of medical intervention: psychotherapeutic, hormonal and surgical, may be appropriate for different personal experiences of gender dysphoria. Surgery may involve realignment of genitalia, gonads and secondary sexual characteristics to accord, as closely as possible, with the gender identity experienced by the individual. Many individuals have struggled with their condition for many years before seeking treatment and may be feeling quite desperate. They and their families are in need of a great deal of support and understanding. Some may even have self-administered hormones or hormone blockers, available from other sources, e.g., the internet. The GP will need to take account of this when treating individuals, or referring them for treatment elsewhere.

[children/adolescents should be referred to a specialist clinic. n.b. symptoms in younger patients do not always translate into transsexualism in an adult. See Annexes (5)& (6)]

For the treatment of adult gender dysphoria/transsexualism, the following protocol is appropriate:

It is important that the GP is able to build a rapport with the patient. If the GP feels unable to support a patient requiring treatment for gender dysphoria, prompt referral to a more empathetic local GP should be made. The GP and patient should discuss together:

• the patient’s history of, and present experience of, gender status discomfort
   
• the possibility, if the individual wishes it, for family members to be included in support of the individual and, also, to help the family understand the condition. relevant literature (e.g.GIRES leaflet) is available for family members.
    
• the possible care pathway as seen by the patient as well as the GP.

The GP should take a full patient medical history, especially:

• any venous-thrombo-embolic disease; family history will be relevant – thrombophilic screening may be considered.
    
• The GP may identify possible providers of care, in addition to GP care and refer to a specialist care provider, i.e. Gender Identity Clinic, either directly or via a local specialist psychiatric source.
    
• The GP should note that it is important, where the referral is to a local psychiatrist, that this practitioner has some experience in the field of gender dysphoria/transsexualism. The first appointment should be achieved within three months of referral from the GP. (less if possible)
    
• the GP may initiate other treatments such as facial hair removal and speech therapy for trans women. Referral for rhinoplasty (nose remodelling) and thyroid chondroplasty (tracheal shave) and, occasionally breast augmentation may also be sought (nb. a specialist surgeon is advisable as the sternum may be more prominent than in other women); and, for trans men patients, referral for double mastectomy may be appropriate. (Guide available for FtM London in conjunction with Mr Dai Davies, Consultant Surgeon. Info@ftmlondon.org.uk) Any additional local care, possibly involving specialist nursing, social services, local liaison psychiatric support. Where the latter is required, it is especially important that the psychiatrist (or psychologist) is able to build a rapport with the patient. Where this is not the case, an alternative practitioner should be commissioned.
    
• The GP is likely to be the source of on-going administration of hormones (see below), although the initial prescription and dosage may have emanated from a specialist Endocrinologist or a specialist Psychiatrist, both of whom may be independent or part of a Gender Identity Clinic team.
    
• The GP should also liaise with the Gender Identity Clinic or independent clinician responsible for the initial prescription, once treatment has started, to ensure continuity of treatment and that no unnecessary, non-clinical delay occurs during the course of treatment leading to surgery (where that is sought).
    
• Explore with the patient the various options available for preserving reproductive capacity (such as gamete storage) and explain the effect of hormone therapy and surgery on fertility. Provide specific information about local, private or NHS facilities suitable for storage of gametes and encourage the patient to think about whether they might wish to have a family in due course. This is especially important in younger people who may not have considered having a family thus far.
    
• It is inappropriate and may be considered misconduct for the psychiatrist to assume that a patient who opts for gamete storage, or has already done so, is in any way equivocal about, or not committed to, the transition process.
   
• The GP should, where requested, provide a letter confirming that the individual is undergoing transitional treatment for transsexualism, for the purposes of changing documentation, e.g., obtaining a new record of name and gender from the Registrar General, passports and driving licences, and authorising the use of appropriate changing and toilet facilities. Where an employer is unaware of the patients situation, certificates for time off work may need to be carefully worded so as not to breach confidentiality.
    
• If the patient transfers to another Primary Care Trust, the GP should take responsibility for liaising with that Trust, in order to ensure smooth transfer and continuity of funding and treatment. Where a patient has already embarked on RLE and can show evidence of role change over a period of time, whether in a treatment centre or at the individual's own volition, this must be given full acknowledgement in the ongoing treatment plan. Patients should not be made to restart RLE from the beginning so the GP should assist by forwarding such information to the Psychiatrist or Gender Identity Clinic who will be providing future treatment.
    
• Post-surgery, the GP may need to co-ordinate support care services, such as a District Nurse, home-help etc. See Annex B (6) (7) (8a) (Annex B may be used in conjunction with NHS consent forms for additional information about post surgical complications.
    
• Prostate glands will shrink with hormone treatment but, as a precautionary measure for those who transition later in life, PSA level checks for prostate abnormalities may be undertaken.
    
• the GP must be aware that, where full surgical transition is not possible or appropriate, on-going psychological support systems and hormonal treatment should be available.

   

Specific Monitoring and Treatment Protocol for Adult Trans Women

 

• Increased morbidity has been described, in trans patients who are being treated with hormone therapy. This particularly applies to trans women patients. An increased risk of thrombo-embolism has also been described, which may be related to raised prolactin levels. However, this may have been the result of excessive dosage in the level of hormones used, particularly oestrogens. Modern therapy can effectively inhibit the secretion of the undesired gonadal hormone rapidly. With the use of exogenous dosage of oestradiol, rather than equine oestrogens which cannot be measures in blood nor, therefore, monitored, the oestrogen levels can be kept within the normal female physiological range. Hopefully, therefore, the increased risk should not occur.

Before hormone treatment commences:

General examination to include: full medical history, and family medical history, physical examination

• Blood pressure, urine, weight, height; calculation of body mass index (BMI)
    
• Where the patient is over 45 and/or there are relevant symptoms, check for pelvic malignancies prostate or other genital abnormalities:

Recommended laboratory tests for baseline levels:

• Serum testosterone, sex-hormone binding globulin, oestradiol, LH & FSH, prolactin, free-thyroxin TSH liver function tests (LFT), urea and electrolytes, FBC, fasting cholesterol and triglycerides.
    
• All the implications of embarking on hormone treatments must be discussed in full, including potential, unwanted side effects and any irreversible effects. The GP should ensure that this discussion has taken place either between him/herself and the patient, or between any other relevant clinician and the patient. An INFORMED CONSENT FORM (Annex B[1][2] may be used in conjunction with NHS consent forms) must have been made available to the patient at least 4 weeks prior to the commencement of treatment; it must be discussed and signed by the GP or other clinician and the patient. The information must be presented in such a way that the patient has the capacity to comprehend it, and to make a decision based on it. At present no individual can give or withhold consent to treatment on behalf of another person (unless mental health legislation applies). If the GP has not been a party to the completion of the form, he/she should have sight of it and should discuss its contents with the patient. Methods of hormone delivery include: oral, injectable and transdermal systems.
    
• Prior to commencing treatment, patients should also be advised that smoking is contra-indicated, especially where surgery is eventually anticipated. The combination of excessive alcohol and hormone treatment can be dangerous. Alcohol should be limited to 14 units a week at most. Obesity is also an added health risk.
    
• Trans women treated with oestrogens can expect: breast growth, some redistribution of body fat, decreased upper body strength, softening of the skin, decrease in body hair, slowing or stopping the loss of scalp hair, decreased fertility and testicular size, less frequent, less firm erections and decreased libido
    
• Most of these changes are reversible although breast enlargement may not be entirely so, except through surgical intervention.
    
• Patients should be advised that cessation of hormones for a few weeks (prior to surgery) will cause beard growth to return, especially where hair-removal treatments are incomplete.
    
• Advise that the effect of hormones on the breasts will be to make them lumpy and tender for a while. Teach the patient how to examine her own breasts as they develop

   

Hormone Treatment of Trans Women (Mimms and BNF should be consulted for additional information regarding contra-indications of specific medications)

Hormones are usually prescribed by Endocrinologist or specialist Psychiatrist, either practising independently or as part of a Gender Identity Clinic team, where treatment protocols have been agreed with the team’s Endocrinologist. However, hormones may be prescribed by a specialist GP or other doctor specialising in the field, in accordance with a regimen agreed by a specialist Endocrinologist. As stated above, the following protocol is a suggested guide, and should not be followed rigidly, but tailored to the individual’s need.

• It has been conventional to try to inhibit male hormone action using the antiandrogen Cyproterone Acetate (CPA), using a dose of 100mg daily (perhaps delivered in two doses) While this is effective, it can cause liver abnormalities and depression. A safer and more effective alternative is to use a depot injection of an analogue of the gonadotrophin releasing hormone such as Goserelin. This is usually started as a 3mg subcutaneous pellet injected every four weeks or a larger dose can be given three monthly by subcutaneous injections. This inhibits secretion of the pituitary gonadotrophins and testosterone secretion producing a " chemical castration". This therapy is without side-effects as long as hormone replacement with oestrogens is given. Dianette (low dose cyproterone and E2) may also be used as it is less hepatotoxic than high dose CPA and may be used with oestrogen/progesterone combinations Low dose Finasteride, which blocks conversion of androgens to the more active testosterone, may also be given to discourage male-pattern hair loss.
    
• Oestrogen is best administered as oestradiol, which is the physiological oestrogen, which can be monitored in blood. Other oestrogen formulations, such as ethinyl oestradiol, or equine oestrogens (e.g. Premarin) are not physiological human hormones and cannot be measured in the blood nor related to normal physiological level.
   
• The starting dose of oestradiol is 2 mg daily. Alternatively for trans women over 40 years old, transdermal patches may be recommended as they may lessen the risk of deep vein thrombosis (dosage of between 50 and 150mcg used two to three times per week with measurements of oestrodial level at 24 or 48 hours after application, aiming to achieve a level at between 400 and 600pmol/l). This dosage will be combined with Goserelin or Cyproterone Acetate.

   

Monitoring Ongoing Hormone Treatment of Trans Women

• general and emotional health
    
• After 2 to 3 weeks serum oestradiol levels should be monitored and a standard time point after the tablet is solid, e.g. at 24 hours after the tablet is taken, or 48 hours after the application of a patch. At this time circulating oestradiol levels of between 600 and 800 pmol. per litre should be the aim, i.e. high follicular phase levels. Dosage of oestradiols should then be increased or decreased to achieve this therapeutically desirable range.
   
• Circulating LH, FSH and oestradiol levels to be monitored as indicated above until an effective, therapeutic regimen is established.
    
• Thereafter, fasting glucose, circulating lipids, liver function tests, haemoglobin and prolactin should be measured six monthly for one year, and then yearly.
    
• Serum prolactin monitoring may cease after three years if it remains in the normal range.
    
• During and following this period, blood pressure and weight should be checked at 3, 6 and 12 months and yearly thereafter.
    
• Check legs for any signs of Deep Vein Thrombosis (DVT)
    
• The surgeon may require the patient to cease hormone treatment for up to 6 weeks prior to surgery. Patients should be made aware that this may be a distressing period during which they experience mood swings

Hormone Treatment & Monitoring Post-Surgery for Trans Women

• From 4 weeks post-operatively resume oestradiol (or other oestrogen treatment) in low doses, building to 2mg daily (plus antiandrogens, short-term only, if necessary to support on-going hair removal treatment)
   
• Dose regimens need to be monitored once again, as above, to ensure that the dose requirements remain the same. It is wise to undertake DEXA bone scans to be sure that bone density remains normal on the oestrogen replacement therapy in the orchidectomised patient, yearly for six years, then from time to time depending on the age of the patient.
    
• Check BP, weight, urinalysis, oestradiol and cholesterol and prolactin levels at 1, 2 and 3 years post-operatively, then, cease, if test results are stable and no hyperprolactaemia occurs.
    
• In line with other women having oestrogen treatment, trans women should be monitored for breast cancer , when they are over 50 and have a family history of the condition.
    
• Note that a height reduction could indicate osteoporosis.

• GPs should be aware that surgery may include orchidectomy, penectomy, vaginoplasty, clitoroplasty and labiaplasty. The most usual technique involves penile skin inversion. Sexual sensation is an important objective in vaginoplasty and clitoroplasty, along with the creation of a functional vagina.
    
• See Annex B (6) (7) (8a) (may be used in conjunction with NHS consent forms) for additional information regarding post surgical complications.

   

Specific Monitoring & Treatment Protocol for Adult Trans Men

Before treatment commences, general examination to include:

• Patient’s full medical history and any relevant family medical history. Ultrasound scan of pelvis will be adequate for those who have not been sexually active. Cervical cytology should be done for those who have been sexually active, unless they have had two ‘normal’ smears during the past three year period. If an internal vaginal examination and smear test is deemed necessary, the patient should have a full explanation of the reasons for this. Medical practitioners should be aware that trans men may feel particularly sensitive to this examination and may refuse it. This refusal must not prejudice ongoing treatment. It is the duty of the GP [or other specialist] to be sure that the patient has had a full and adequate explanation of any adverse implications of this refusal. (See Annex B[8b]) for suggested Informed Refusal form.
    
• BP, weight, height, calculation of BMI, urinalysis
    
• Regular examination of breasts should continue where the family history indicates a predisposition to developing breast cancer.

Laboratory tests:

• FBC, renal and liver, bone (calcium & phosphate), free thyroxin TSH, fasting cholesterol, triglycerides and glucose, LH, FSH, oestradiol, testosterone and prolactin.
    
• Scan for detection of ovarian cysts and fibroids
    
• All the implications of hormone treatments must be discussed in full, including potential, unwanted side-effects, such as cardio-vascular disease (any family history of CV disease or diabetes is relevant) and any irreversible effects, such as deepening of the voice and growth of facial hair. The GP should ensure that this discussion has taken place either between him/herself and the patient, or between any other relevant clinician and the patient. An INFORMED CONSENT FORM (Annex B[3] may be used in conjunction with NHS consent forms) must have been discussed and signed by the GP or other clinician and the patient. If the GP has not been a party to its completion, he/she should have sight of the form and should discuss its contents with the patient. The information must be presented in such a way that the patient has the capacity to comprehend it, and to make a decision based on it. At present no individual can give or withhold consent to treatment on behalf of another person (unless mental health legislation applies).
    
• Individuals should be warned of the increased risk if they smoke, drink alcohol in excess of 14 units a week or are significantly overweight. The GP should offer relevant advice where these factors are present.
    
• The patient should be advised that menstruation will cease between 3 and 6 months after the commencement of treatment; by three months, the voice will have deepened and beard growth will be starting. Between 9 months and 12 months, male-pattern facial hair will become established.
    
• The patient should be advised that once treatment commences, the breasts should be checked regularly especially prior to mastectomy and in the over 50s; any abnormal vaginal bleeding should be reported

   

Hormone Treatment for Trans Men (Mimms and BNF should be consulted for additional information regarding contra-indications of specific medications)

Hormones are usually prescribed by Endocrinologist or specialist Psychiatrist at a Gender Identity Clinic, where treatment protocols have been agreed with the team’s Endocrinologist, but may be prescribed by a specialist GP or other doctor who specialises in the field, in accordance with the protocol agreed by a specialist Endocrinologist. The following protocol is a suggested guide, and should not be followed rigidly, but tailored to the individual’s need.

• If an internal vaginal examination/cytology has not been performed at an earlier stage, and is still deemed advisable, there is now a further opportunity for the GP to raise the issue again, giving the patient a full explanation of the reasons. As stated above, medical practitioners should be aware that trans men may feel particularly sensitive to this examination and may refuse it. This refusal must not prejudice their ongoing treatment. It is the duty of the GP (or other specialist) to be sure that the patient has had a full and adequate explanation of any adverse implications of this refusal. A form indicating Informed Refusal should be signed by patient and practitioner (Annex B[8b])
    
• Goserelin depot injections, or alternative similar preparation, should be started together with a depot testosterone injection such as testosterone emanthate of 250 mg intramuscularly each two weeks. After 2 such injections voice changes are largely irreversible except by surgical intervention, (see Annex A[4]) An alternative to an injection of testosterone is the use of oral testosterone Undecanoate which unlike other oral testosterone preparations does not have hepatotoxic effects. Usual doses will be 120-160 mg daily.

   

Monitoring of Hormone Treatment of Trans Men

• After 2 to 3 injections, serum testosterone levels should be measured, just before an injection is due. A level just above or just below the lower end of the normal male range of serum testosterone is the desirable level at the time of the next injection. Levels at this point, at or above the middle of the normal male range, will lead to accumulation of excessive levels of testosterone in the ten days after an injection, which is likely to have an adverse effect on the arterial system and on haemoglobin.

Monitoring of Goserelin Dose in Trans Men

 

• Serum LH and FSH levels should be obtained, 2 – 3 weeks after Goserelin is given, to demonstrate full suppression of pituitary gonadotrophin levels. This is best done after the second and/or third injection.

Also During the First year at three months, six months and twelve months( and thereafter yearly)

• assess patient’s psychological and physical wellbeing
    
• BP, weight and urine tests, legs should be checked for peripheral oedema
    
• Check breasts where age and/or family history indicate raised risk
    
• Renal, liver, fasting cholesterol, and triglycerides prolactin levels, LH and FSH, oestradiol, testosterone (and dihydrotestosterone if appropriate) as indicated above, to ensure that an adequate dosage regimen is established.
    
• Post-oophorectomy and Hysterectomy,
    
• Androgen (testosterone) treatment may be resumed from 4 weeks post-operatively
   
• Warn that alcohol intake should be limited to 21 units per week,
    
• Assess the patient’s psychological and physical condition
    
• BP, weight, check legs for oedema
    
• Check renal, liver, fasting cholesterol, and prolactin levels, triglycerides, LH and FSH, oestradiol, testosterone (and dihydrotestosterone if appropriate) at 3 months, as indicated above, to ensure that an adequate dosage regimen is re-established. Ongoing blood tests should no longer be necessary unless risk factors exist. Androgen treatment will continue unless contra-indicated. Regular examinations for breast cancer should continue, even after mastectomy, depending on age and family history.

Ongoing Possible Surgical Procedures – Phalloplasty

GPs should have an overall understanding of the possible procedures.

Not all trans/men seek phalloplasty, but if they do, the implications should be discussed in full and properly informed consent given, as with all other procedures. This will be done with the surgeon.

• The GP may need to refer the individual for electrolysis or for laser treatment, in order to remove hair from the donor site.
    
• the individual needs to understand that phalloplasty involves several surgical procedures over a period of time.
   
• The GP should be aware, broadly speaking, of the possible alternative levels of surgery available. Procedures may include: metoidoplasty (creation of micropenis), scrotoplasty, urethroplasty (penis through which urine may be excreted), placement of testicular prosthesis, and phalloplasty, a full sized penis and/or a penis which can be made erect.

Post – surgery

• The individual will require the same care as any other patient following major surgery with particular attention to the donor-site care. District & Practice nurses may be involved if the patient returns home with a catheter in situ.