INTRODUCTION

THIS INFORMED CONSENT (THE"CONSENT") FOR TESTOSTERONE REPLACEMENT THERAPY INJECTIONS (“TRT INJECTION”) SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (COLLECTIVELY, THE"MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").

The purpose of this consent is to provide you with information about the risks, benefits, and safety considerations associated with TRT injections in order for you to make an informed decision as to whether or not to proceed with treatment, as well as to obtain your agreement to adhere to the treatment protocol as prescribed by yourMedical Group healthcare provider (“Healthcare Provider”). Please read this form carefully and ask any questions you have before signing.

GENERAL INFORMATION

There are different forms of testosterone replacement therapy available, including transdermal topical gel or cream, intramuscular injection (TRT Injection), subdermal pellets injected under the fat layer just below the skin that release testosterone over time, and sublingual troches. Your Medical Group provider has recommended intramuscular injection of testosterone cypionate.

The FDA approves testosterone therapy for men who lack or have low testosterone levels in conjunction with an associated medical condition. Other uses may be considered off label.The safety and efficacy of testosterone supplementation for off label use is not established. Many individuals have inadequate testosterone levels despite technically normal blood tests. In such cases, testosterone replacement therapy can be used to augment testosterone levels in a number of conditions where diminished hormone levels are evident. Lifestyle modifications such as diet and exercise, sufficient sleep, and stress reduction have also proven to improve overall health and hormone levels. Testosterone replacement therapy is used to treat symptoms or when lab tests suggest suboptimal hormone levels. In such case, testosterone replacement therapy is implemented to optimize testosterone levels in the blood, helping to reduce symptoms associated with lower levels.Potential benefits can include: increased energy, increased sex drive, increased bone density, weight loss, increased muscle mass, better sleep and decreased anxiety. However, no benefits are or lack of side effects are guaranteed.

Testosterone replacement may be prescribed from standard or compounding pharmacies.

The Medical Group providers prescribe testosterone therapy only in appropriate cases. Nevertheless, in order to reduce uncertainties and potential risks, patients who are prescribed testosterone replacement must agree to have adequate lab testing and physical examination as recommended by their Medical Group provider. Testosterone refills will not be issued if the required testing and follow up reviews with your provider are not followed as prescribed.

All patients are encouraged to get routine male urological screening done based on their age. If a patient presents with symptoms of possible BPH, the patient may be required to see their PCP or urologist for a digital rectal exam (DRE) before initiating or continuing any treatment.
There is some risk, even with bioidentical testosterone therapy, of enhancing an existing current prostate cancer to grow more rapidly.For this reason, a rectal exam and prostate specific antigen (PSA) blood testis recommended to be completed before starting testosterone and every 12 months thereafter. If there are any questions about possible cancer, an ultrasound of the prostate gland may be required as well as a referral to a qualified specialist. You may be asked to sign a PSA and/or rectal exam waiver if you fail to have these yearly.

As with all therapies, there are potential benefits and risks.

Potential Benefits of Testosterone Replacement Therapy:

According to The Endocrine Society, testosterone therapy can improve sexual concerns, bone health, muscle and anemia (low red cells in the blood).Additional potential benefits, according to the published literature, include increase in skeletal muscle mass, strength and power, self-reported mobility, and some measures of physical function, as well as modest improvement in depressive symptoms, quality of life, and improved glucose tolerance in men with Type 2 diabetes.

Potential Risks and Side Effects for Male Testosterone Replacement Therapy

The American College of Physicians states: “Evidence from 20 observational studies with a mean follow-up ranging from 0.73 to 10.3 years showed no increased risk for mortality, cardiovascular events, prostate cancer, or pulmonary embolism or deep venous thrombosis.”

The most extensive study to date examined prostate safety during testosterone replacement in men with hypogonadism (testosterone deficiency). The results were that there was not any statistical significance compared to men in the placebo group regarding an increased incidence of prostate cancer, acute urinary retention, invasive surgical procedures, prostate biopsy, and International Prostate Symptom Score.However, PSA levels did increase more in the testosterone group than in the placebo group.

A separate large study examined the cardiovascular safety of testosterone-replacement therapy in middle aged and older men between the ages of 45 to 80 years who had preexisting or a high risk of cardiovascular disease with hypogonadism(testosterone deficiency). Daily transdermal testosterone had less incidence of cardiovascular events compared to placebo.

While these studies showed a high degree of safety, side effects could still occur with long-term use. The most common side effect of TRT is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels as well as those listed below.

The following is a list of some common possible side effects of TRT:

‍Acne: Testosterone therapy may increase oil production in the skin, and potentially lead to acne. ‍
Hair thinning: While this is rare, it may be due to the conversion of testosterone to an excess amount of DHT (dihydrotestosterone) in the hair follicles. This can be managed by taking over-the-counter supplements, DHT-blocking shampoos, or by using a DHT-blocking medication, which your provider can prescribe.‍
Changes in Mood: Some patients can become more aggressive, irritable or have other subtle mental health changes such as more hostile mood while on testosterone replacement.‍
Breast Enlargement and Nipple or breast sensitivity: Because testosterone breaks down into estrogen, TRT can cause breast enlargement (also called gynecomastia) and breast/nipple tenderness. Some men have a higher tendency to convert the additional testosterone to estrogen. Your provider monitors this with scheduled blood testing, and the risk can be reduced by reducing the testosterone or by taking an estrogen-blocking medication.‍
Testicular shrinkage and reduced sperm production: Adding testosterone from an external source trigger the testicles to reduce natural testosterone production, and sperm production, and thus the testicle may shrink in size. Therefore, TRT can result in decreased size of the testicles (testicular atrophy) and decreased sperm production resulting in infertility. If you are planning to have children, then you should be aware that testosterone therapy can significantly reduce sperm production and cause infertility. ‍
Elevated red blood cell levels: Testosterone may stimulate the bone marrow to produce more red blood cells, a condition called erythrocytosis (high concentration of red blood cells), which can cause the blood to thicken and can increase the risk of blood clots leading to potential risk of blood clots in the legs or lungs, strokes and heart attacks, including Deep Vein Thrombosis (DVT) and Venous Thromboembolism (VTE).We monitor this with regular blood testing. Donating blood every 2-3 months can also help control this. You may need to stop your TRT if your red blood cell count increases too much. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Signs and symptoms of a stroke include inability to move or feel certain parts of the body. ‍
Growth of metastatic prostate cancer: TRT does not cause prostate cancer; however, if you have prostate cancer that has not yet been diagnosed, it can grow with the use of testosterone replacement. ‍
Sleep Apnea: TRT may worsen or cause sleep apnea which can cause sleep disturbance, headaches, increased blood pressure and fatigue. This is more likely inpatients with lung diseases or that are overweight.
‍Increased Prostate Size: It is possible that testosterone replacement can increase prostate size, leading to a condition called benign prostatic hypertrophy (BPH), which can make it hard to urinate. If you already have an enlarged prostate, your signs and symptoms may worsen while taking TRT.These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
‍Increased PSA levels: TRT can increase PSA levels which may lead to increased risk of detecting subclinical prostate cancer.‍
Liver irritation: Testosterone can irritate the liver in some people, so you need to have regular liver function tests. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).‍
Fluid retention: Some men on testosterone therapy may retain fluid. This can cause problems with patients that have heart, kidney, or liver disease. Symptoms can include swelling of your ankles, feet, or body (edema), with or without heart failure.‍
Potential for Abuse. Testosterone can be abused when taken at higher than-prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.

Additionally, any time the skin is punctured, there is a risk of infection even if all proper precautionary measures are taken.

These are not all the possible side effects of TRT.

Testosterone containing medications are a controlled substance as designated by the DEA and should be stored in a safe and secure place to prevent unauthorized access and use. Keeping this medication in a locked box, locked cabinet, or safe is recommended. It is against federal regulation to sell, share, or distribute this prescription to anyone for whom it has not been prescribed.

Alternatives

‍There are often various options for treating the symptoms of declining testosterone levels as they develop with non-hormonal therapies such as herbal therapies, dietary supplements, and lifestyle modifications such as nutrition, physical exercise, weight loss, stress reduction etc.

Contraindications

You should not use testosterone replacement therapy if any of the following apply to you:

Have breast cancer or a history of breast cancer;
Have had or might have prostate cancer or current PSA over 4 ng/mL and nodules upon digital rectal exam unless cleared by urologist or oncologist
Serious Heart, Liver, or Kidney Disease
Hematocrit over 48%(polycythemia)
Planning to have children in the next year or potentially thereafter
Known Hypersensitivity to anything in the drug
Testosterone is a controlled substance (CIII). It is not known if testosterone is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children.
Testosterone is not meant for use by women. Any use by women of child-bearing age is prohibited as testosterone is teratogenic and may harm the unborn baby.
Testosterone can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

Additional Important Safety Information Regarding TRT

If your blood pressure increases while taking TRT, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed, or new blood pressure medicines may need to be added to control your blood pressure. If your blood pressure cannot be controlled, your TRT may need to be stopped.
Your Medical Group healthcare provider will monitor your blood pressure while you are being treated with TRT.
Before you take TRT, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking TRT with certain other medicines can cause adverse effects. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicines and pain medicines.

TREATMENT PROTOCOL

Your Healthcare Provider will determine the appropriate dosage of based on laboratory testing and medical history.

Once your hormone levels and symptoms are optimized, you will be placed on a maintenance dose. Most men areon the protocol for at least 6-12 months and many continue for multiple years.

In order to continue receiving prescriptions, you will be required to complete laboratory testing before initiating treatment, three months after starting treatment, and then annually thereafter, unless otherwise indicated by your clinician in the event of a dose change or the occurrence of side effects.

It is very important you follow your provider’s instructions. You agree not to change your dosing of testosterone to manipulate your hormone levels in order to increase the amount of testosterone prescribed to you.

USE OF TELEHEALTH

You understand that all Clinical Services will be provided via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location.Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following:

electronic transmission of client medical records, photo images, personal health information or other data between a patient and a provider;
interactions between a patient and provider via audio, video and/or data communications (such as messaging or email communications);
use of output data from medical devices, sound and video files.
Alternative methods of care may be available to you, such as in-person services, and you may choose an alternative at any time.

Electronic systems used will incorporate network and software security protocols to protect the confidentiality of customer identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.

EXPECTED BENEFITS OF TELEHEALTH:

Improved access to care by enabling a customer to remain at a remote site while consulting with practitioners at distant/other sites.
More efficient client evaluation and management.
Obtaining expertise of a distant specialist.

POSSIBLE RISKS OF TELEHEALTH

There are potential risks associated with the use of telehealth. These risks include, but may not be limited to:

There is the potential that conditions that could be diagnosed with an in-person visit may go undetected in a remote encounter especially because a full physical exam cannot be performed;
In rare cases, information transmitted may not be sufficient (e.g. poor resolution of images) to allow for appropriate decision making by the Healthcare Provider;
Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment;
In very rare instances, security protocols could fail, causing a breach of privacy of personal health information;
In rare cases, a lack of access to complete health records may result in interactions or allergic reactions or other judgment errors.

Due to state licensure requirements for healthcare providers, you have to be physically present in the state in which your Healthcare Provider is licensed during your telehealth visit. By agreeing to this Consent, you are confirming that you will only opt in to care when you are in your state of residence or in one of our locations. Furthermore, you are confirming that your state of residence is one in which the Medical Groups are licensed to treat.

PLEASE NOTE: THE MEDICAL GROUPS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, ARE CONSIDERING HARMING YOURSELF OR OTHERS, OR ARE OTHERWISE IN IMMINENT DANGER, YOU SHOULD DIAL 9-1-1 AND/OR GO TO THE NEAREST EMERGENCY ROOM.

You should seek emergency help or follow-up care when recommended by any healthcare provider or when otherwise needed. You should never discontinue medications or stop a course of treatment without first contacting your primary care provider or other medical professionals for advice. You should not delay treatment or advice from your primary care provider or other medical professionals based on information provided by the Healthcare Provider(s) via the Superpower Platform.

All laws and protections for in-person medical care also apply to telehealth care. This includes confidentiality of information, access to medical records, and sharing of information that could identify you personally. You may decide that you do not want to use the Clinical Services at any time, seek treatment elsewhere and/or with in-person offerings.

INFORMED CONSENT & ADHERENCE TO TREATMENT PLAN

Please sign below to acknowledge your understanding and agreement of the following terms in order to proceed with treatment with Testosterone Replacement Therapy via Injections with a Medical Group Healthcare Provider via the SuperpowerPlatform:

BY SIGNING THIS INFORMED CONSENT,YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDED ABOUT TRT INJECTION TREATMENT, INCLUDING THE RISKS, BENEFITS, AND SAFETY CONSIDERATIONS. YOU AGREE TO ADHERE TO THE TREATMENT PROTOCOL AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER AND TO REPORT ANY SEVERE SIDE EFFECTS OR CONCERNS TOYOUR HEALTHCARE PROVIDER PROMPTLY.

Take your medication exactly as directed and written on your prescription label. By FDA law, this medication is not for resale, nor can it be returned for refund. Do not let anyone else take your medication. This medication is intended for use solely by the person for whom it is prescribed and should not be shared with any other individuals.Please follow the directions of your prescribing Healthcare Provider and on your prescription label carefully. If you need further explanation or have questions, please ask your prescribing Healthcare Provider to explain any part you do not understand.

You understand that the Healthcare Provider prescribing TRT holds a professional license issued by the professional licensing board or agency in the state where they practice. You can report a complaint relating to the care provided by contacting the appropriate state professional licensing board.

NO GUARANTEES

You acknowledge that there are no guarantees or assurances made with respect to the results of taking the TRT Injections prescribed for you, and there are no guarantees that there will not be side effects and complications.

COMPLETE MEDICAL HISTORY

You understand that TRT injections may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your prescribing HealthcareProvider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your Medical Group prescribing Healthcare Provider updated as to any changes in your health conditions and history during treatment with TRT, and you agree there shall be no liability on the part of the Medical Groups, the Healthcare Providers or Superpower if you fail to do so.

CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT: BY CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE TRT INJECTIONS THROUGH THIS SERVICE. YOU CERTIFY THAT YOU ARE NOT CONSENTING ON BEHALF OF AMINOR CHILD, AS THIS SERVICE DOES NOT PROVIDE TREATMENT TO INDIVIDUALS UNDER THE AGE OF 18.

I confirm and agree that: I have read this entire Informed Consent, and I understand and agree to the information herein. I understand this is an elective treatment. The nature of the therapy, and the potential risks, benefits and alternatives have been explained to me, and I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction. I hereby freely and voluntarily accept all risks associated withTRT Injections and elect and consent to proceed with treatment.

MEMBER NAME:___________________________

SIGNATURE:_____________________________

DATE:__________________________________

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Informed Consent for Testosterone Replacement Therapy Injections (TRT Injections)