Consent to Medical Treatment

Estrogen: Information Leaflet and Consent Form for Use in Feminising Treatment

1. Medication Details:

Estrogen refers to a group of sex hormones responsible for the development and regulation of the ovarian reproductive system and development and maintenance of feminine secondary sexual characteristics. It is available in several forms, including oral tablets, transdermal patches, injections, and topical gels or creams.

2. Uses and How It Works:

In the context of gender-affirming hormone therapy, estrogen is used to induce feminisation in transgender women and transfeminine individuals. It works by promoting the development of female secondary sexual characteristics (such as breast development, redistribution of body fat, and skin softening) and reducing masculine features.

3. Potential Benefits:

- Development of female secondary sexual characteristics.
- Decreased libido and reduced spontaneous erections.
- Reduction in gender dysphoria and improvement in psychological well-being.
- Possible decrease in male-pattern hair growth and balding.

4. Possible Risks and Side Effects:

- Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism).
- Elevated blood pressure.
- Weight gain and fluid retention.
- Breast tenderness and enlargement.
- Emotional changes, including mood swings and depression.
- Liver function abnormalities

- These risks match the risk seen by cisgender women

5. Warnings:

- Estrogen therapy is associated with an increased risk of thromboembolic events, especially in people who smoke or have a personal or family history of clotting disorders.
- Long-term use of estrogen may increase the risk of breast cancer, gallbladder disease, and liver conditions to the same rate as cisgender women.

6. Cautions:

- People taking estrogen should have their health monitord in the same way a cisgender women would.

7. Contraindications:

- Estrogen-dependent neoplasia (e.g., certain types of breast cancer).
- Undiagnosed vaginal bleeding.
- Pregnancy.
- Active or recent history of arterial thromboembolic disease (e.g., stroke, myocardial infarction).

8. Dosage and Administration:

- The dosage of estrogen varies based on the individual's needs, route of administration, and specific formulation. 
- Estrogen therapy is often combined with an antiandrogen for more effective feminisation.

9. Monitoring and Follow-Up:

- Regular follow-up appointments every 3 to 6 months to monitor hormone levels, efficacy, and side effects of the treatment.
- Annual comprehensive evaluations to assess general health.

10. Summary:

Estrogen therapy plays a central role in feminising hormone therapy, offering significant benefits in the physical and psychological well-being of transgender women and transfeminine individuals. Awareness of potential risks and adherence to monitoring protocols are essential to ensure safe and effective treatment.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Progesterone: Information Leaflet and Consent Form for Use in Feminising Treatment

1. Medication Details:

Progesterone is a natural hormone involved in the menstrual cycle, pregnancy, and embryogenesis. It is also used in hormone therapy, available in various forms such as oral capsules and vaginal/rectal suppositories.

2. Uses and How It Works:

In gender-affirming hormone therapy, progesterone is sometimes used to complement estrogen therapy for transgender women and transfeminine individuals. It works by contributing to the development of secondary female sexual characteristics, potentially aiding in breast development and the distribution of body fat.

3. Potential Benefits:

- May enhance breast development and the feminisation process when used in conjunction with estrogen.
- Could contribute to improved mood and emotional wellbeing.
- Might aid in achieving a more typical female body fat distribution.

4. Possible Risks and Side Effects:

- Mood changes, including depression.
- Bloating and weight gain.
- Breast tenderness and potential engorgement.
- Increased risk of venous thromboembolism (VTE), especially in combination with estrogen.
- Possible changes in lipid profile and cardiovascular risk.

- These risks match the risk seen by cisgender women

5. Warnings:

- Progesterone should be used with caution in individuals with a history of mood disorders, as it can exacerbate such conditions.
- The combination of progesterone with estrogen may increase the risk of thromboembolic events; monitoring and preventive measures are advised.

6. Cautions:

- Use with caution in patients with a history of cardiovascular diseases, liver dysfunction, or those at risk for VTE.
- Regular monitoring of lipid profiles and liver function tests is recommended.

7. Contraindications:

- Known hypersensitivity to progesterone or any of the formulation's components.
History of or current venous thromboembolic disorders, such as deep vein thrombosis or pulmonary embolism.
- Active or recent arterial thromboembolic diseases like stroke or myocardial infarction.
- Breast cancer or other hormone-sensitive cancers, unless specifically directed by a healthcare provider.

8. Dosage and Administration:

- Dosage varies based on individual needs, form of progesterone, and concurrent hormone therapy regimens. It is essential to follow the prescribing physician's instructions accurately.

9. Monitoring and Follow-Up:

- Regular follow-up appointments to monitor the effectiveness and side effects of the therapy.

10. Summary:

Progesterone is sometimes used in gender-affirming hormone therapy to complement the effects of estrogen. While it may offer additional benefits in feminisation, it's crucial to be aware of the potential side effects and risks. Informed consent and regular monitoring are vital to ensure safe and effective treatment.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Testosterone: Information Leaflet and Consent Form for Use as an Hormone in Masculinising Treatment

1. Medication Details:

Testosterone is the primary male sex hormone that plays a key role in the development of XY reproductive tissues and secondary sexual characteristics. It is available in various forms, including injections, transdermal patches, gels, and cream formulations.

2. Uses and How It Works:

Testosterone is used in gender-affirming hormone therapy to promote masculinisation in transgender men and transmasculine individuals. It works by inducing the development of masculine secondary sexual characteristics, such as increased muscle mass, deeper voice, and facial and body hair growth.

3. Potential Benefits:

- Development of masculine physical traits.
- Redistribution of body fat to a more masculine pattern.
- Increase in muscle mass and strength.
- Potential deepening of the voice.
- Growth of facial and body hair.
- Improvement in psychological well-being and reduction in gender dysphoria.

4. Possible Risks and Side Effects:

- Acne and oily skin.
- Increased red blood cell count (polycythemia), which can increase the risk of blood clots.
- Changes in cholesterol levels and increased risk of cardiovascular disease.
- Mood swings and increased aggression.
- Potential for liver toxicity with oral formulations.
- Balding or hair thinning in individuals with a predisposition to male pattern baldness.

5. Warnings:

- Health risks will be the same as those experienced by cisgender men.

6. Cautions:

- Regular monitoring of hematocrit is recommended to manage the risk of polycythemia and cardiovascular disease.

7. Contraindications:

- Known or suspected breast or prostate cancer.
- Uncontrolled heart failure.
- Untreated severe sleep apnea.

8. Dosage and Administration:

- The dosage of testosterone varies based on the individual's needs, route of administration, and specific formulation. Tailor the dosage to achieve the desired masculinising effects while minimising side effects.

9. Monitoring and Follow-Up:

- Regular follow-up appointments to monitor testosterone levels, efficacy, and side effects of the treatment.
- Monitoring of hematocrit and overall health at follow-up appointments, typically every 3 to 6 months.

10. Summary:

Testosterone therapy is a cornerstone of masculinising hormone therapy, providing significant benefits for transgender men and transmasculine individuals seeking to align their physical appearance with their gender identity. Awareness of potential risks and commitment to regular monitoring are crucial to ensure the safe and effective use of testosterone.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Finasteride: Information Leaflet and Consent Form for Use as an Antiandrogen in Feminising Treatment

1. Medication Details:

Finasteride is a prescription medication designed to inhibit 5-alpha-reductase, an enzyme responsible for converting testosterone to dihydrotestosterone (DHT). By reducing DHT levels, finasteride impacts processes influenced by this hormone.

2. Uses and How It Works:

Apart from treating benign prostatic hyperplasia (BPH) and male pattern hair loss, finasteride is also used off-label as an antiandrogen in feminising hormone therapy for transgender women and transfeminine individuals. It works by lowering DHT levels, which can contribute to the desired reduction in masculinising features and support the development of feminising physical changes.

3. Potential Benefits:

- In Feminising Therapy: May contribute to a decrease in body and facial hair growth, and in combination with estrogen, support the development of a more typically feminine appearance.
- For BPH and Hair Loss: Reduces urinary retention risks and promotes hair regrowth.

4. Possible Risks and Side Effects:

- Sexual dysfunction (decreased libido, erectile dysfunction, ejaculation disorder)
- Breast tenderness and enlargement
- Mood changes, including depression
- Very rarely, high-grade prostate cancer

5. Warnings:

- Not suitable for use by cisgender women, especially when pregnant, due to the risk of causing birth defects.
- Changes in breast tissue, like lumps or nipple discharge, should be reported immediately.

6. Cautions:

- Finasteride should not be handled by people who are or may become pregnant, as it can cause birth defects.

7. Contraindications:

- Known allergic reactions to finasteride or its components.
- Pregnant individuals or those who may become pregnant.

8. Dosage and Administration:

- For feminising therapy, the dosage should be determined by a provider specialising in transgender care. 5mg for femisiation, 1mg for prevention of hair loss.
- Typically taken once daily, with or without food.

9. Monitoring and Follow-Up:

- Regular assessments to monitor the effectiveness and any adverse effects of the treatment.
- Follow-up appointments every 6 to 12 months, or as recommended by the healthcare provider.

10. Summary:

Finasteride can play a role in feminising hormone therapy by reducing the effects of DHT. While it offers benefits in reducing masculinising features, it's crucial for people to understand the potential side effects and the importance of monitoring and follow-up. Informed consent ensures people are fully aware and agree to the treatment plan.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Spironolactone: Information Leaflet and Consent Form for Use as an Antiandrogen in Feminising Treatment

1. Medication Details:

Spironolactone is a potassium-sparing diuretic that also acts as an antiandrogen. It inhibits the action of male hormones (androgens) in the body, which can contribute to certain medical conditions.

2. Uses and How It Works:

Spironolactone is used in the treatment of conditions like hirsutism (excessive hair growth), acne, and as part of feminising hormone therapy for transgender women and transfeminine individuals. It works by blocking androgen receptors and inhibiting the production of androgens.

3. Potential Benefits:

- Reduces the effects of androgens, which can decrease acne, scalp hair loss, and body and facial hair growth.
- In feminising hormone therapy, it supports the development of feminine physical features by reducing masculinisation.

4. Possible Risks and Side Effects:

- Hyperkalemia (high potassium levels in the blood)
- Diuresis (increased urination)
- Electrolyte imbalances
- Fatigue, dizziness, and headache

5. Warnings:

- Regular monitoring of potassium levels is essential to avoid hyperkalemia, a potentially life-threatening condition.
- Spironolactone should not be used in patients with severe kidney impairment, acute renal failure, or significant renal insufficiency.

6. Cautions:
- Use with caution in patients with liver disease, as spironolactone can affect liver function.
- Patients with a history of heart conditions should be monitored due to the risk of electrolyte imbalances affecting cardiac function.

7. Contraindications:

- Known hypersensitivity to spironolactone.
- Anuria (absence of urine production), acute renal insufficiency, or significant impairment of renal excretory function.
- Hyperkalemia or conditions predisposing to hyperkalemia.

8. Dosage and Administration:

- Dosage varies based on the condition being treated and patient response. For feminising hormone therapy, dosages typically range from 100 to 200 mg per day, divided into one or two doses.

9. Monitoring and Follow-Up:

- Regular monitoring of blood potassium and renal function is required.
- Patients should have follow-up appointments every 3 to 6 months to assess the effectiveness and side effects of the treatment.

10. Summary:

Spironolactone is an effective antiandrogen that can reduce the effects of testosterone hormones in the body, supporting the treatment of conditions like hirsutism, acne, and aiding in feminising hormone therapy. People must be aware of the potential side effects and the need for regular monitoring to use this medication safely.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Cyproterone: Information Leaflet and Consent Form for Use as an Antiandrogen in Feminising Treatment

1. Medication Details:

Cyproterone acetate is a synthetic steroidal antiandrogen, with progestogen and antigonadotropic properties. It is used to reduce the effects of testosterone hormones (androgens) in the body, which can contribute to conditions such as severe acne, hirsutism, and is also used in gender-affirming hormone therapy.

2. Uses and How It Works:

Cyproterone works by blocking the effects of androgens, thereby reducing unwanted androgenic effects. It is particularly effective in conditions exacerbated by androgens and is used in the management of androgen-dependent conditions.

3. Potential Benefits:

- Reduction in the signs of androgenisation, such as severe acne and hirsutism.
- In gender-affirming therapy, it helps in achieving a more feminine physical appearance by reducing masculinising features.

4. Possible Risks and Side Effects:

- Liver toxicity, including rare cases of liver failure.
- Weight changes, fluid retention.
- Depressive mood changes.
- Decreased libido and erectile dysfunction.
- Breast tenderness.
- Possible increased risk of venous thromboembolism (VTE).

5. Warnings:

- Cyproterone acetate has been associated with cases of severe liver injury. Liver function tests should be regularly monitored.
- Menigioma brain tumours have been very rarely reported.

6. Cautions:
- Caution is advised in people with diabetes, as cyproterone can affect glucose tolerance.
- People with a history of thromboembolic disorders should be aware of an increased risk of blood clots an increased risk of VTE..

7. Contraindications:

- Known hypersensitivity to cyproterone acetate or any of the ingredients.
- Presence of severe liver diseases.
- History of or existing venous thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism).
- Dubin-Johnson syndrome and Rotor syndrome.
- Meningioma or history of meningioma.

8. Dosage and Administration:

- The dosage of cyproterone acetate varies depending on the condition being treated, typically ranging from 12.5mg to 50mg daily. For gender-affirming therapy, dosages and administration schedules should be tailored to the individual's needs and in accordance with medical guidelines.

9. Monitoring and Follow-Up:

- Regular monitoring of liver function is required.
- People should observe for signs of depressive symptoms and other mood changes.
- Regular follow-up appointments are essential to monitor the efficacy and side effects of the treatment.

10. Summary:

Cyproterone acetate is an effective antiandrogen used in the treatment of androgen-dependent conditions and gender-affirming hormone therapy. While it offers significant benefits, it is essential for patients to be aware of the potential risks and the importance of regular monitoring and follow-up to ensure safe use of the medication.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Gonadotropin-Releasing Hormone Analogues (GnRHa) for Use as an Hormone Blocker in Gender-Affirming Treatment

1. Medication Details:

Gonadotropin-Releasing Hormone Analogues (GnRHa) are synthetic peptides designed to mimic the natural gonadotropin-releasing hormone, leading to suppression of sex hormone production.

2. Uses and How It Works:

GnRHa are used in various conditions, including prostate cancer, endometriosis, uterine fibroids, and as part of gender-affirming hormone therapy for transgender individuals. They work by decreasing the production of sex hormones (estrogen and testosterone) to a very low level.

3. Potential Benefits:

- Reduction in the effects of the sex hormones estrogen and testosterone, aiding in the management of conditions like prostate cancer and assisting in gender-affirming care.
- Decreased risk of symptoms associated with conditions like endometriosis and uterine fibroids.

4. Possible Risks and Side Effects:

- Initial "flare" effect where symptoms may temporarily worsen due to the initial surge in hormone levels.
- Hot flashes, decreased libido, mood changes, and fatigue.
- Decreased bone density with long-term use.
- Injection site reactions for depot formulations.

5. Warnings:

- Long-term use without hormone replacement requires careful consideration due to the risk of bone density loss..

6. Cautions:

- Use with caution in individuals with a history of osteoporosis or bone health issues.
- Mental health should be monitored due to the potential impact of hormone suppression on mood and wellbeing.

7. Contraindications:

- Known hypersensitivity to GnRHa or any of their excipients.
- Pregnancy and breastfeeding due to the potential effects on fetal development.

8. Dosage and Administration:

- Dosage and administration depend on the specific GnRHa used and the condition being treated. For gender-affirming therapy, dosages are tailored to individual treatment goals and should be determined by a provider experienced in transgender healthcare.

9. Monitoring and Follow-Up:

- Regular monitoring of hormone levels and bone density is recommended, especially with long-term use.
- Follow-up appointments should be scheduled to assess treatment response, side effects, and any necessary adjustments to therapy.

10. Summary:

GnRHa offer a powerful option for the suppression of sex hormones in various medical conditions, including as part of gender-affirming hormone therapy. While effective, it is important for people to be aware of the need for regular monitoring to ensure safe and effective treatment.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

Raloxifene as a Feminizing Medication: Information Leaflet and Consent Form

1. Medication Details:

Raloxifene is a selective estrogen receptor modulator (SERM) that exerts estrogenic effects on certain tissues while acting as an estrogen antagonist on others. It is commonly used in the prevention and treatment of osteoporosis in postmenopausal women and is also used off-label in gender-affirming therapy.

2. Uses and How It Works:

In the context of gender-affirming hormone therapy, raloxifene is sometimes considered for its estrogenic effects on bone density and its potential role in breast development. It binds to estrogen receptors, mimicking the effects of estrogen in some tissues.

3. Potential Benefits:

- May contribute to the prevention of bone loss and promote bone health in transgender women, especially those at risk for osteoporosis.
- Potentially limits breast development although evidence is limited and varies among individuals.

4. Possible Risks and Side Effects:

- Hot flashes and leg cramps.
- Increased risk of venous thromboembolism (VTE), similar to estrogen therapy.
- Possible liver function abnormalities.
- Gastrointestinal disturbances such as nausea and vomiting.

5. Warnings:

- Raloxifene should be used with caution in individuals with a history of or current risk factors for thromboembolic disorders.
- People should be advised of the signs and symptoms of blood clots and instructed to seek immediate medical attention if they experience any.

6. Cautions:

- The safety and efficacy of raloxifene for feminizing effects in transgender women have not been thoroughly studied, and its use should be considered experimental.

7. Contraindications:

- Known hypersensitivity to raloxifene or any component of the formulation.
- History of or active venous thromboembolic events, such as deep vein thrombosis or pulmonary embolism.
- Pregnancy and lactation, due to potential adverse effects on the fetus or newborn.

8. Dosage and Administration:

- The dosage in the context of gender-affirming therapy may vary and should be determined by a provider experienced in transgender care. The typical dosage for osteoporosis prevention is 60mg once daily.

9. Monitoring and Follow-Up:

- Regular follow-up appointments to monitor for efficacy and side effects.

10. Summary:

Raloxifene is a SERM used primarily for osteoporosis treatment in postmenopausal women and may have off-label use in gender-affirming therapy for transgender women. While it offers potential benefits for bone health and possibly breast development, it carries risks similar to estrogen therapy, particularly regarding thromboembolic events. Informed consent and careful monitoring are essential for individuals considering raloxifene as part of their hormone therapy.

Note: This document is for informational purposes and does not replace medical advice. Consult a healthcare professional for individualised treatment and care.

PDE5 Inhibitors for Erectile Dysfunction: Information Leaflet and Consent Form

1. Medication Details:

PDE5 Inhibitors, including Sildenafil (Viagra), Tadalafil (Cialis), Vardenafil (Levitra), and Avanafil (Stendra), are medications used for the treatment of erectile dysfunction (ED). They function by enhancing blood flow to the penis, aiding in achieving and maintaining an erection.

2. Uses and How It Works:

These medications specifically target the phosphodiesterase type 5 (PDE5) enzyme in the penile tissue, thereby promoting relaxation of blood vessels and increased blood flow. This action aids in the development and maintenance of an erection in response to sexual stimulation.

3. Potential Benefits:

- Improvement in the ability to achieve and maintain an erection.
- Increased satisfaction with sexual intercourse.
- Positive impact on self-esteem and quality of life.

4. Possible Risks and Side Effects:

- Common side effects include headaches, facial flushing, indigestion, nasal congestion, and dizziness.
- Rare but serious side effects include sudden hearing loss, vision changes, or priapism (a prolonged, painful erection).
- Should not be used with nitrates or certain other medications due to potential serious interactions.

5. Warnings:

- Individuals with cardiovascular conditions should use these medications with caution.
- Not recommended for use in individuals with severe liver or kidney impairment.

6. Cautions:

- Patients should inform their healthcare provider of their full medical history and all medications they are taking.
- If experiencing chest pain, nausea, or dizziness during sexual activity, seek immediate medical attention.

7. Contraindications:

- Known hypersensitivity to any components of the medication.
- Concurrent use of nitrates in any form, or certain other medications.

8. Dosage and Administration:

- Dosage varies depending on the specific medication and individual health needs.
- Typically taken orally, with or without food, prior to sexual activity.

9. Monitoring and Follow-Up:

- Regular follow-up is essential to assess effectiveness and address any side effects or concerns.
- Dosage adjustments may be required based on individual response and side effects.

10. Summary:

PDE5 inhibitors are a viable treatment option for erectile dysfunction, offering potential improvements in sexual function. However, it is crucial to use these medications under the guidance of a healthcare provider, considering their potential side effects and interactions with other medications.

Note: This document is for informational purposes only and does not replace professional medical advice. Consult your healthcare provider for personalised treatment and care.

https://www.ema.europa.eu/en/documents/product-information/cialis-epar-product-information_en.pdf