Informed Consent

(From Catherine White Holman Wellness Centre www.cwhwc.com)

Estrogens and Testosterone Blockers for Trans* Clients

What is informed consent?
Before starting hormone treatment, it is important to understand the
possible benefits, risks, warning signs, and alternatives. You and your
healthcare provider will work together to make sure you have all the
information you need to decide if hormone treatment is right for you.
Agreeing to start hormone treatment once you know all of the benefits,
risks, warning signs, and alternatives, and have had all of your questions
answered, is called informed consent.
What are the different medications that can feminize my
appearance?
Part of transition for many trans* people involves taking hormones. For
hormone treatment to be most effective, most people who were
assigned male at birth take not only estrogens (female hormones), but
also androgen blockers to prevent their body from producing or utilizing
testosterone (male hormones).
What is estrogen and how is it taken?
Different forms of the hormone estrogen are used to change your
appearance and how you feel. Estrogen can be given as an injection
(weekly or every other week), as a pill (daily or twice a day), or as a
patch (which is changed every three or four days).
What are androgen blockers and how are they taken?
Medications that block the production or effects of testosterone are
called androgen blockers. Androgen is another term for male sex
hormones. Spironolactone is the androgen blocker that is most
commonly used in Canada. It is a pill that you swallow once or twice a
day. Other medicines are sometimes used, but because spironolactone
is relatively safe, inexpensive, and effective, it is the primary androgen
blocker.
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Benefits, Risks, Warnings and Alternatives
Benefits (* means it is a permanent change)
Physical changes including:
softer skin
slower growth of body hair
slowed hair loss on head
change in body fat shape: more on hips, less on belly
breast development*
decreased muscle mass
decreased spontaneous erections
smaller testicles*

Risks
blood clots including thrombophlebitis or pulmonary embolus (blood
clot in the lung)
more risk of stroke
emotional changes
headache
high blood pressure (hypertension)
infertility
inflamed liver
interaction with drugs for diabetes and blood thinning — for example
Warfarin
more risk of diabetes or cholesterol change
more risk of heart disease
less sex drive and spontaneous erection
unknown risk of breast cancer and possible interference in assessing
for prostate cancer
risk of disturbance to body’s potassium leading to dizziness or heart
rhythm abnormality (spironolactone)
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Warning: Who should not take estrogen?
Estrogen should not be used by anyone who has a history of:
an estrogen-dependent cancer
a disorder that makes them more likely to get blood clots that could
travel to the lungs (unless they are also taking blood thinners and are
followed by a specialist)

Estrogen should be used with caution and only after a full

discussion of risks by anyone who:
has a strong family history of breast cancer or other cancers that grow
quicker when estrogens are present
has uncontrolled diabetes
has heart disease
has chronic hepatitis or other liver disease
has uncontrolled high cholesterol
has migraines or seizures
is obese
smokes cigarettes

Alternatives
Not all trans* people choose to take hormones. It is up to you whether or
not they want to take them, and it will not affect how you are treated at
this clinic.
There are alternatives to using feminizing medications to help people
change their physical gender. If you are interested in alternatives to
hormone treatment, talk to your clinician about your options. Page 39
Please initial each statement to show you understand the benefits,
risks, and changes that may occur from taking these medications.
Informed Consent: Physical Changes
_____ Estrogen or anti-androgens – or both – may be prescribed to
cause changes in my appearance that are typically considered feminine.
_____ It can take several months or longer for the effects to become
noticeable. No one can predict how fast or how much change will
happen.
_____ If I am taking estrogen, I will develop breasts.
It takes several years for breasts to get to their full size.
The breasts will remain, even if I stop taking estrogen.
I might have a milky discharge from my nipples — galactorrhea. If I
do, I know I should check it out with my clinician because it could be
caused by the estrogen or by something else.
While we do not know the exact risk, my risk of breast cancer may be
increased to as high as if I had been born female
I should take care of my breasts. This includes breast exams from my
health provider, and regular mammograms after a certain age.

_____ The following changes are usually not permanent — they are
likely to go away if I stop taking the medicines.
Body hair will become less noticeable and will grow more slowly, but it
won’t stop completely, even if I take the medicines for years.
I will probably have less fat on my abdomen and more on my buttocks,
hips, and thighs — changing from apple shape to pear shape.
If I have the predisposition to have male pattern baldness it may start
later than it would have, but may not stop completely.
If I stop taking hormones I may lose my hair faster than if I hadn’t
taken hormones.
I know I may lose muscle and strength in my upper body
I know that my skin may become softer.
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_____ My body will make less testosterone. This may affect my sex life
in different ways and future ability to cause a pregnancy:
My sperm may no longer get to mature. This could make me less able
to cause a pregnancy. There is a small risk that I might never produce
mature sperm again. It’s also possible that my sperm could still mature
even while I am taking hormones. I might get someone pregnant if we
have vaginal intercourse and we don’t use birth control.
options for sperm banking have been explained to me.
My testicles may shrink down to half their size. They are still part of
my body and I need to take care of them unless I have surgery to
remove them. This means that I will need regular checkups for them.
I won’t have as much semen when I ejaculate.
It is likely that I won’t be hard in the morning as often as before. And it
is likely that I will have fewer spontaneous erections.
I may not be able to get hard enough for penetrative sex.
I may want to masturbate or have sex less and may find it harder to
orgasm when I do.
I know this treatment may (but is not assured to) make me
permanently unable to make someone pregnant.

_____ Some parts of my body will not change much by using these
medicines.
I know the hair of my beard and mustache may grow more slowly than
before. It may become less noticeable, but it will not go away unless I
have treatments like electrolysis.
I know the pitch of my voice will not rise, and my speech patterns will
not change.
I know my Adam’s apple will not shrink.
Although these medicines can’t make these changes happen, there
are other treatments that may be helpful.
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_____ There may be mood changes with these medicines. My care
providers will check in regularly about how my mood is. I know there are
mental health resources available to me if I need them.
Informed Consent: Risks
Risks of Estrogens and Androgen-Blocking Medications
_____ The side effects and safety of these medicines are not completely
known. There may be long-term risks that are not yet known.
_____ I know not to take more medicine than I am prescribed. This
increases health risks. Taking more than I am prescribed won’t make
changes happen more quickly or more significantly.
_____ These medicines may damage the liver and may lead to lead to
liver disease. I will require regular blood tests for possible liver damage
as long as I take them.
_____ These medicines cause changes that other people will notice.
Some transgender people have experienced discrimination because of
this. My clinician can help me find advocacy and support resources.
_____ I know that a minority of people (1-3%) will later regret their
decision to take hormone therapy. I know that under these
circumstances some physical changes that occurred while on hormone
therapy will be irreversible.
Risks of Estrogen
_____ Taking estrogen increases the risk of blood clots or problems with
blood vessels that can result in:
chronic problems with veins in the legs
heart attack
pulmonary embolism – blood clot to the lungs – which may cause
permanent lung damage or death
stroke, which may cause permanent neurologic damage or death
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_____ The risk of blood clots is much worse if I smoke cigarettes. The
danger is so high that I should stop smoking completely if I start taking
estrogen. I know that I can ask my clinician for advice about how to stop
smoking.
_____ Taking estrogen can increase the deposits of fat around my
internal organs. This can increase my risk for diabetes and heart
disease.
_____ Taking estrogen can raise my blood pressure. If it goes up, my
clinician can work with me to try to control it with diet, lifestyle changes,
and/or medication.
_____ Taking estrogen increases my risk of getting gallstones. I should
talk with my clinician if I get severe or long-lasting pain in my abdomen.
_____ Estrogen can cause nausea and vomiting. I should talk with my
clinician if I have long-lasting nausea or vomiting.
_____ Estrogen can cause migraines or make them worse if I already
have them. I should talk with my clinician if I have headaches or
migraines often or if the pain is unusually severe.
_____ It is not yet known if taking estrogen increases the risk of
prolactinomas. These are non-cancerous tumors of the pituitary gland.
They are not usually life threatening, but they can damage vision and
cause headaches if they are not treated properly. Changes in vision,
headaches that are worse when I wake up in the morning, and milky
discharge from my nipples can be signs of a prolactinoma, and I should
talk to my health care provider if I develop these symptoms. There is a
blood test that can check for this that will be ordered regularly.
_____ I am more likely to have dangerous side effects if:
I smoke.
I am overweight.
I have a personal or family history of blood clots.
I have a personal or family history of heart disease and stroke.
My family has a history of breast cancer.
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Risks of Androgen Antagonists
_____ Spironolactone affects the balance of water and salts in the
kidneys. This may:
Increase the amount of urine I produce, making it necessary to urinate
more frequently.
Increase thirst.
Rarely, cause high levels of potassium in the blood, which can cause
changes in heart rhythms that may be life-threatening.
Reduce blood pressure.

_____ Cyproterone has the potential to damage my liver and my

clinician will monitor my liver with blood tests.
_____ Some androgen antagonists make it more difficult to evaluate test
results for cancer of the prostate. This can make it more difficult to check
up on prostate problems. If I am over 50, I should discuss appropriate
prostate cancer screening with my care provider. Even if I have genital
sex reassignment surgery the prostate is not usually removed.
Informed Consent: Prevention
Prevention of Medical Complications
_____ I agree to take medications as prescribed. I agree to tell my care
provider if I have any problems or am unhappy with the treatment.
_____ The dose and type of medication that’s prescribed for me may not
be the same as someone else’s.
_____ I need periodic physical exams and blood tests to check for any
side effects.
_____ In addition to periodic checks from my provider, I must also treat
my body with respect. This means that paying attention and talking to
my provider if I develop any symptoms that might be side effects from
medicines. Page 44
_____ These medications can interact with other drugs and prescribed
and over the counter medicines. These include alcohol, diet
supplements, herbs, other hormones, and street drugs. This kind of
interaction can cause complications. I need to prevent complications
because they can be life-threatening. That’s why I need to be keep my
clinician informed about whatever else I take. I also know that I will
continue to get medical care here no matter what I share about what I
take.
_____ Even if I have to stop my estrogens, I may still be able to take the
testosterone blockers that I am on, to help prevent the effects of my
body producing testosterone again.
_____ Using these medicines to feminize is an off-label use. I know this
means it is not approved by Health Canada. I know that the medicine
and dose that is recommended for me is based on the judgment and
experience of my health care provider and the best information that is
currently available in the medical literature.
_____ I can choose to stop taking these medicines at any time. If I
decide to do that, I should do it with the help of my clinician. This will
help me make sure there are no negative reactions.
_____ My clinician may suggest that I reduce my dose or stop taking
estrogens or blockers at all if certain conditions develop. This may
happen if the side effects are severe or there are health risks that can’t
be controlled.
Informed Consent: Alternatives
_____ Not all trans* people choose to take hormones and my decision
about whether to take them or not will not affect how I am treated at this
clinic.
_____ There are alternatives to using feminizing medicines to help
people change their physical gender. Some trans* people choose to not
take hormones or have surgery and may only socially transition. If I am
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interested in alternatives, I can talk with my health care provider about
my options.
Signature
My signature below confirms that:
My clinician has talked with me about:
the physical changes and risks of taking feminizing medication;
warnings and prevention of medical complications; and
potential alternative treatments

I understand the risks that may be involved.

I know the information in this form includes the known effects and risks.
I understand that there may be unknown long-term effects of risks.
I understand that counselling can be beneficial for some people who are
considering hormone therapy (support through the decision-making
process, support with coming out, adjusting to the physical and
emotional changes that may come with hormone therapy, etc.) and my
provider has let me know about counselling and support options that are
available to me.
I have had enough opportunity to discuss treatment options with my
clinician. All of my questions have been answered to my satisfaction.
I believe I know enough information to give informed consent to take,
refuse, or postpone therapy with feminizing medications.
Based on all this information:
_____ I want to begin taking estrogen
_____ I want to begin taking androgen antagonists (e.g., spironolactone)
_____ I do not wish to begin taking feminizing medication at this time
Client Signature ___________________________________________
Date: ___________________ Page 46