Patient Name: {{patient_first_name}} {{patient_last_name}} DOB: {{patient_birthdate}}

Off-Label Consent

It is important that you understand the risks and benefits associated with Hormone Replacement Therapy (HRT) before beginning or continuing treatment. HRT is not a new area of medicine, however the treatment modalities may involve innovative therapies and there are no guarantees with respect to the treatment prescribed. You should also be aware of alternatives to HRT, including not receiving HRT treatment, leaving hormone levels as they are, and treating age-related diseases and symptoms as they appear. It is important that you consider the information we provide and discuss the information carefully with your provider. Be sure that you are doing what is right for you. If you are unsure, then you should refuse and/or discontinue treatment.

Many women and men suffer from symptoms associated with inadequate hormone levels. Women may have symptoms that include the inability to lose weight, vision loss due to macular degeneration, sleep difficulties, hot flashes, night sweats, decreased cognitive function, decreased libido, fatigue, mood changes, and bone loss. Men's symptoms may include inability to lose weight, loss of exercise stamina, sleep difficulties, decreased cognitive function and focus, decreased libido, erection difficulties, fatigue and mood changes. These symptoms may be treatable utilizing hormone replacement. The therapeutic objective of HRT is to optimize hormone levels, helping to reduce these symptoms and improve overall health.

The medications that may be prescribed as part of treatment may include Estrogen, Progesterone, Testosterone, HCG anti-estrogen medication thyroid medications, DHEA, Vitamins D, B12 and or B complexes, where indicated. The recommended treatment in some instances may include "off-label" drug use of FDA-approved medications. For example, testosterone is only FDA-approved for use in men. Off-label use means use of FDA-approved medications for additional indications, for a different population or in a different dosage or form than it was clinically tested. Treating physicians and nurse practitioners can determine to prescribe drugs off label when it is in the best interest of the patient based on credible, published supporting scientific data and if the risks do not outweigh the benefits.

"This is my consent to begin treatment for Hormone Replacement Therapy."

Check the box next to "Agree" if you agree with the following statement:
I am not pregnant and I do not plan to become pregnant.

☐ Agree

Check the box next to "Agree" if you agree with the following statement:
I have read and understand, that there may be complications arising from or related to treatment as described above, and explained by my treating medical provider. I have had an opportunity to discuss my complete past medical and health history including any serious problems and/or injuries, as well as my family history of diseases and conditions, with my provider. All my questions concerning the risks, benefits, and alternatives to treatment have been answered. I am satisfied with the answers and desire to commence treatment, knowing the risks and potential side effects involved.

☐ Agree

Check the box next to "Agree" if you agree with the following statement:
I understand that HRT is purely elective and that it may not be deemed medically necessary by insurance companies. I have the option to decline treatment, seek alternative treatment or seek the same treatment from a different practitioner or different health care practice.

☐ Agree

Check the box next to "Agree" if you agree with the following statement:
I understand that I will have periodic blood tests to monitor my blood levels of each hormone and I consent to such testing. I understand that the physical exam performed here does NOT replace a full physical exam by my personal physician, and I agree to have primary care physician perform a full physical exam including a lipid profile, mammogram and pap smear/pelvic exam (if applicable) annually.

☐ Agree

Check the box next to "Agree" if you agree with the following statement:
I understand that each patient is different and there are no guarantees as to the results obtainable from HRT treatment. HRT is not a cure, and if I stop treatment, symptoms may return or worsen. I understand that this form covers known effects and risks and that there may be long-term effects or risks that are not known yet.

☐ Agree

Check the box next to "Agree" if you agree with the following statement:
I certify that I have read the above consent and fully understand it. I believe I have adequate knowledge on which to base informed consent to start HRT.

☐ Agree

Patient Signature: Date: {{current_date}}

Provider Signature Date: {{current_date}}

Medical Services provided by Primary Medical of KY, P.S.C., Elite Health Services, P.A., CO., Primary Medical of IN, P.C.
2025.07.09

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Off-Label Consent

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2026-03-03 09:12:15 EDT

Off-Label Consent Uploaded by EnnuLife Patient Docs - docs-admin-ennulife@ennulife.com IP 24.238.5.27

2026-03-09 12:25:16 EDT

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