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Male Patient Questionnaire & History Name: Today s Date: (Last) (First) (Middle) Date of Birth: Age: Weight: Occupation: Home Address: City: State: Zip: Home Phone: Cell Phone: Work: E-Mail Address: May we contact you via E-Mail? ( ) YES ( ) NO In Case of Emergency Contact: Relationship: Home Phone: Cell Phone: Work: Primary Care Physician s Name: Phone: Address: Address City State Zip Marital Status (check one): ( ) Married ( ) Divorced ( ) Widow ( ) Living with Partner ( ) Single In the event we cannot contact you by the mean s you ve provided above, we would like to know if we have permission to speak to your spouse or significant other about your treatment. By giving the information below you are giving us permission to speak with your spouse or significant other about your treatment. Spouse s Name: Relationship: Home Phone: Cell Phone: Work: Social History: ( ) I am sexually active. ( ) I have completed my family. ( ) I have used steroids in the past for athletic purposes. ( ) I smoke (cigarettes or cigars) a day. ( ) I drink alcoholic beverages drinks, times per week. ( ) I use caffeine cups per day. New Male Patient Package Page Number: 1 Revision Date 4-4-2015

Medical History Any known drug/environmental (i.e. tape/adhesive) allergies: Have you ever had any issues with anesthesia? ( ) Yes ( ) No If yes please explain: Medications Currently Taking: Current Hormone Replacement Therapy: Past Hormone Replacement Therapy: Nutritional/Vitamin Supplements: Surgeries, list all and when: Other Pertinent Information: Medical History: ( ) High blood pressure. ( ) High cholesterol. ( ) Heart Disease. ( ) Stroke and/or heart attack. ( ) Blood clot and/or a pulmonary emboli. ( ) Hemochromatosis. ( ) Depression/anxiety. ( ) Psychiatric Disorder. ( ) Cancer (type): Year: ( ) Testicular or prostate cancer. ( ) Elevated PSA. ( ) Prostate enlargement. ( ) Trouble urinating or taking Flomax or Avodart. ( ) Chronic liver disease (hepatitis, fatty liver, cirrhosis). ( ) Diabetes. ( ) Thyroid disease. ( ) Arthritis. I understand that if I begin testosterone replacement with any testosterone treatment, including testosterone pellets, that I will produce less testosterone from my testicles and if I stop replacement, I may experience a temporary decrease in my testosterone production. Testosterone Pellets should be completely out of your system in 12 months. By beginning treatment, I accept all the risks of therapy stated herein and future risks that might be reported. I understand that higher than normal physiologic levels may be reached to create the necessary hormonal balance. New Male Patient Package Page Number: 2 Revision Date 4-4-2015

BHRT CHECKLIST FOR MEN Name: Date: E-Mail: Symptom (please check mark) Never Mild Moderate Severe Decline in general well being Joint pain/muscle ache Excessive sweating Sleep problems Increased need for sleep Irritability Nervousness Anxiety Depressed mood Exhaustion/lacking vitality Declining Mental Ability/Focus/Concentration Feeling you have passed your peak Feeling burned out/hit rock bottom Decreased muscle strength Weight Gain/Belly Fat/Inability to Lose Weight Breast Development Shrinking Testicles Rapid Hair Loss Decrease in beard growth New Migraine Headaches Decreased desire/libido Decreased morning erections Decreased ability to perform sexually Infrequent or Absent Ejaculations No Results from E.D. Medications Family History Heart Disease Diabetes Osteoporosis Alzheimer s Disease NO YES New Male Patient Package Page Number: 3 Revision Date 4-4-2015

Testosterone Pellet Insertion Consent Form Bio-identical testosterone pellets are concentrated, compounded hormone, biologically identical to the testosterone that is made in your own body. Testosterone was made in your testicles prior to andropause. Bio-identical hormones have the same effects on your body as your own testosterone did when you were younger. Bio-identical hormone pellets are made from soy and bio-identical hormone replacement using pellets has been used in Europe, the U.S. and Canada since the 1930 s. Your risks are similar to those of any testosterone replacement but may be lower risk than alternative forms. During andropause, the risk of not receiving adequate hormone therapy can outweigh the risks of replacing testosterone. Risks of not receiving testosterone therapy after andropause include but are not limited to: Arteriosclerosis, elevation of cholesterol, obesity, loss of strength and stamina, generalized aging, osteoporosis, mood disorders, depression, arthritis, loss of libido, erectile dysfunction, loss of skin and muscle tone, diabetes, increased overall inflammatory processes, dementia and Alzheimer s disease, and many other symptoms of aging. CONSENT FOR TREATMENT: I consent to the insertion of testosterone pellets in my hip. I have been informed that I may experience any of the complications to this procedure as described below. Surgical risks are the same as for any minor medical procedure. Side effects may include: Bleeding, bruising, swelling, infection and pain and possible extrusion of pellets. Lack of effect (typically from lack of absorption). Thinning hair, male pattern baldness. Increased growth of prostate and prostate tumors. Hyper sexuality (overactive libido). Ten to fifteen percent shrinkage in testicle size. There can also be a significant reduction in sperm production. There is some risk, even with natural testosterone therapy, of enhancing an existing current prostate cancer to grow more rapidly. For this reason, a prostate specific antigen blood test is to be done before starting testosterone pellet therapy and will be conducted each year thereafter. If there is any question about possible prostate cancer, a follow-up with an ultrasound of the prostate gland may be required as well as a referral to a qualified specialist. While urinary symptoms typically improve with testosterone, rarely they may worsen, or worsen before improving. Testosterone therapy may increase one s hemoglobin and hematocrit. This elevation can be diagnosed with a blood test. Thus, a complete blood count should be done at least annually. This condition can be reversed by donating blood periodically. BENEFITS OF TESTOSTERONE PELLETS INCLUDE: Increased libido, energy, and sense of well-being. Increased muscle mass and strength and stamina. Decreased frequency and severity of migraine headaches. Decrease in mood swings, anxiety and irritability (secondary to hormonal decline). Decreased weight (Increase in lean body mass). Decrease in risk or severity of diabetes. Decreased risk of Alzheimer s and Dementia. Decreased risk of heart disease in men less than 75 years old with no pre-existing history of heart disease. On January 31, 2014, the FDA issued a Drug Safety Communication indicating that the FDA is investigating risk of heart attack and death in some men taking FDA approved testosterone products. The risks were found in men over the age of 65 years old with preexisting heart disease and men over the age of 75 years old with or without pre-existing heart disease. These studies were performed with testosterone patches, testosterone creams and synthetic testosterone injections and did not include subcutaneous hormone pellet therapy. I agree to immediately report to my practitioner s office any adverse reactions or problems that may be related to my therapy. Potential complications have been explained to me and I agree that I have received information regarding those risks, potential complications and benefits, and the nature of bio-identical and other treatments and have had all my questions answered. Furthermore, I have not been promised or guaranteed any specific benefits from the administration of bio-identical therapy. I certify this form has been fully explained to me, and I have read it or have had it read to me and I understand its contents. I accept these risks and benefits and I consent to the insertion of hormone pellets under my skin. This consent is ongoing for this and all future insertions. I understand that payment is due in full at the time of service. I also understand that it is my responsibility to submit a claim to my insurance company for possible reimbursement. I have been advised that most insurance companies do not consider pellet therapy to be a covered benefit and my insurance company may not reimburse me, depending on my coverage. I acknowledge that my provider has no contracts with any insurance company and is not contractually obligated to pre-certify treatment with my insurance company or answer letters of appeal. Print Name Signature Today s Date New Male Patient Package Page Number: 4 Revision Date 4-4-2015

HIPAA Information and Consent Form The Health Insurance Portability and Accountability Act (HIPAA) provides safeguards to protect your privacy. Implementation of HIPAA requirements officially began on April 14, 2003. Many of the policies have been our practice for years. This form is a friendly version. A more complete text is posted in the office. What this is all about: Specifically, there are rules and restrictions on who may see or be notified of your Protected Health Information (PHI). These restrictions do not include the normal interchange of information necessary to provide you with office services. HIPAA provides certain rights and protections to you as the patient. We balance these needs with our goal of providing you with quality professional service and care. Additional information is available from the U.S. Department of Health and Human Services. www.hhs.gov We have adopted the following policies: 1. Patient information will be kept confidential except as is necessary to provide services or to ensure that all administrative matters related to your care are handled appropriately. This specifically includes the sharing of information with other healthcare providers, laboratories, health insurance payers as is necessary and appropriate for your care. Patient files may be stored in open file racks and will not contain any coding which identifies a patient s condition or information which is not already a matter of public record. The normal course of providing care means that such records may be left, at least temporarily, in administrative areas such as the front office, examination room, etc. Those records will not be available to persons other than office staff. You agree to the normal procedures utilized within the office for the handling of charts, patient records, PHI and other documents or information. 2. It is the policy of this office to remind patients of their appointments. We may do this by telephone, e-mail, U.S mail, or by any means convenient for the practice and/or as requested by you. We may send you other communications informing you of changes to office policy and new technology that you might find valuable or informative. 3. The practice utilizes a number of vendors in the conduct of business. These vendors may have access to PHI but must agree to abide by the confidentiality rules of HIPAA. 4. You understand and agree to inspections of the office and review of documents which may include PHI by government agencies or insurance payers in normal performance of their duties. 5. You agree to bring any concerns or complaints regarding privacy to the attention of the office manager or the doctor. 6. Your confidential information will not be used for the purposes of marketing or advertising of products, goods or services. 7. We agree to provide patients with access to their records in accordance with state and federal laws. 8. We may change, add, delete or modify any of these provisions to better serve the needs of the both the practice and the patient. 9. You have the right to request restrictions in the use of your protected health information and to request change in certain policies used within the office concerning your PHI. However, we are not obligated to alter internal policies to conform to your request. I, date do hereby consent and acknowledge my agreement to the terms set forth in the HIPAA INFORMATION FORM and any subsequent changes in office policy. I understand that this consent shall remain in force from this time forward. Print Name Signature Today s Date New Male Patient Package Page Number: 5 Revision Date 4-4-2015

Informed Consent BIOTE RESEARCH SUBJECT INFORMED CONSENT FORM Prospective Research Subject: Read this consent form carefully and ask as many questions as you like before you decide whether you want to participate in this research study. You are free to ask questions at any time before, during, or after your participation in this research. Project Title: PTSD Treatment with Bioidentical Pellet Therapy Sponsor: BioTE Clinical & Research Principal Investigators: Mandy Cotten, DNP, Gary Donovitz, MD 1. PURPOSE OF THIS RESEARCH STUDY o Determine how bioidentical hormone pellets and the BioTE Hormone optimization method affect quality of life in veterans 2. PROCEDURES o You will have labs drawn 2-4 times over a years time o You will have bioidentical hormone pellets inserted into the fat tissue on your hip 3-4 times over a years time 3. POSSIBLE RISKS OR DISCOMFORT o All risks associated with therapy are covered on the Testosterone pellet insertion consent form 4. OWNERSHIP AND DOCUMENTATION OF SPECIMENS o You may have access to the results; we may utilize your results to publish regarding pellet therapy. No personal identifiers will be used for the study. 5. POSSIBLE BENEFITS o You will help us demonstrate what has already been published about the benefits of pellet therapy versus synthetic injections. o Other benefits are specified on the testosterone pellet injection consent 6. FINANCIAL CONSIDERATIONS o You will receive $2000 + worth of labs and pellet therapy for free for the duration of the study 7. CONFIDENTIALITY o Your identity in this study will be treated as confidential. The results of the study, including laboratory or any other data, may be published for scientific purposes but will not give your name or include any identifiable references to you. 8. TERMINATION OF RESEARCH STUDY: You are free to choose whether or not to participate in this study. If you choose to not participate in the study, there will be no monetary cost to you. 9. AUTHORIZATION: I have read and understand this consent form, and I volunteer to participate in this research study. I understand that I will receive a copy of this form. I voluntarily choose to participate. Participant Name (Printed): Date: Participant Signature: Date: Principal Investigator Signature: Date: New Male Patient Package Page Number: 6 Revision Date 4-4-2015

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