DESCRIPTION OF TREATMENT
I am being offered oral bioidentical hormone therapy (BHRT), designed specifically for men, using compounded medications prepared by a licensed compounding pharmacy. These medications are not FDA-approved for safety, efficacy, or manufacturing quality, and their use is considered off-label based on individualized clinical assessment.
Oral hormone therapy for men may include:
- Testosterone (oral tablet, off-label use in men)
- DHEA (dehydroepiandrosterone, oral tablet)
- Other hormones as clinically indicated
I understand compounded prescriptions may take 10–14 business days to arrive. While the clinic will make reasonable efforts to avoid delays, I agree to hold the clinic and providers harmless for delays outside their control, including pharmacy backlog, weather, shipping, or supply issues.
IMPORTANT NOTE ABOUT ELECTIVE TREATMENT
I understand:
- This treatment is elective and optional.
- Many men experience symptoms of age-related hormonal decline — such as fatigue, low libido, mood changes, decreased muscle mass, erectile dysfunction, and difficulty maintaining weight or energy — even when blood tests appear normal.
- After individualized evaluation, I may benefit from bioidentical hormone therapy to help reduce symptoms and improve quality of life.
- Long-term safety and effectiveness of compounded BHRT continue to be studied. While many men report benefit, no guarantees can be made regarding long-term outcomes or individual results.
- I have carefully weighed the potential benefits and risks before choosing to proceed.
IMPORTANT GEOGRAPHIC LIMITATION
I understand:
- These services are only available to male residents of Arizona.
- All telehealth appointments must be conducted while I am physically present in Arizona.
- If I leave the state, I will notify the clinic, and care cannot continue unless compliant with Arizona law.
ABOUT TESTOSTERONE THERAPY
Possible benefits may include:
- Supporting libido and sexual function
- Helping maintain muscle mass and strength
- Supporting energy, stamina, and motivation
- Supporting mood, cognition, or mental clarity
- Supporting bone density
- Helping mild fat-to-muscle body composition changes
Possible risks and side effects may include:
- Acne or oily skin
- Hair thinning or male pattern hair loss
- Mood changes, irritability, or aggression (rare)
- Elevated red blood cell count (erythrocytosis)
- Fluid retention or swelling
- Prostate enlargement or symptoms (urinary)
- Worsening of sleep apnea (if present)
- Blood clots, stroke, heart attack (rare)
- Hormone-sensitive tissue stimulation (rare but serious)
- Changes in liver function (such as elevated liver enzymes; liver toxicity or damage is rare)
ABOUT DHEA THERAPY (For men)
Possible benefits may include:
- Supporting mood and sense of well-being
- Supporting energy, stamina, and libido
- Supporting bone density
- Supporting muscle maintenance
- Supporting adrenal health
Possible risks and side effects may include:
- Acne or oily skin
- Increased facial or body hair
- Hair thinning
- Mood changes or irritability
- Hormone-sensitive tissue stimulation (rare but serious)
- Not recommended for men with current prostate cancer or other hormone-sensitive cancers. However men with previous prostate cancer history must get urologist clearance before starting.
OTHER OPTIONS DISCUSSED
I understand alternatives to compounded BHRT include:
- FDA-approved commercial testosterone products (injectable, transdermal, etc.)
- Non-hormonal prescription medications
- Lifestyle changes (diet, exercise, stress management)
- Nutritional or herbal supplements
- Choosing no treatment at this time
IMPORTANT SAFETY NOTICE
- Hormone therapy is not appropriate for men with certain health risks or untreated medical conditions.
- Testosterone and DHEA therapy must not be used if I have a current or past history of prostate cancer or other hormone-related cancers.
- All hormone therapies require individualized discussion, monitoring, and ongoing medical care.
POSSIBLE RISKS AND SIDE EFFECTS (SUMMARY)
Risks and side effects may include, but are not limited to:
- Acne, oily skin, hair thinning
- Mood changes, irritability, aggression (rare)
- Elevated red blood cell count (erythrocytosis)
- Fluid retention, swelling
- Prostate enlargement or urinary symptoms
- Worsening sleep apnea (if present)
- Blood clots, stroke, heart attack (rare)
- Hormone-sensitive tissue stimulation (rare but serious)
- Changes in liver function (such as elevated liver enzymes; liver toxicity or damage is rare)
CONTRAINDICATIONS
I confirm I have disclosed if I have or have had:
- Current or past prostate cancer or other hormone-sensitive cancer
- Stroke, heart attack, or blood clots
- Active liver disease or abnormal liver function
- Severe, uncontrolled hypertension or cardiovascular disease
- Untreated severe sleep apnea
- Elevated PSA (prostate-specific antigen) without urology evaluation
- Allergies to hormone or compound ingredients
ONGOING MEDICAL CARE & CHECKUPS
I understand:
- I must maintain care with my primary care physician, urologist, or specialists.
- I am responsible for routine men’s health screenings, bloodwork , prostate exams and PSA testing as appropriate.
- This therapy does not replace standard cancer screening or urologic care.
VIRTUAL CARE / TELEHEALTH NOTICE
I understand:
- All appointments are via telehealth (virtual consultation).
- Telehealth has limitations, including no physical exams or emergency care.
- I agree to hold WildBerryMD and its providers harmless for telehealth limitations.
- I will seek in-person care from my primary care provider, urologist, urgent care, or emergency services when needed.
- EMERGENCY NOTICE: I understand WildBerryMD does not provide emergency care. In a medical emergency, I will call 911 or go to the nearest emergency room.
NON-FDA APPROVAL & COMPOUNDED MEDICATION NOTICE
I understand:
- Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or manufacturing standards.
- Use of these medications is off-label and based on a careful clinical assessment and my informed decision to proceed.
FINANCIAL RESPONSIBILITY & NO REFUNDS
I understand this is a self-pay, elective program, and no refunds or exchanges will be provided for consultations, medications, or services — even if I choose to stop treatment or am dissatisfied with results.
I understand outcomes are not guaranteed, and individual responses may vary.
INDEMNITY & RELEASE OF LIABILITY
By signing below, I agree to release, indemnify, defend, and hold harmless WildBerryMD, its providers, owners, staff, and affiliated pharmacies from claims, demands, damages, or legal actions arising from:
- My decision to undergo compounded hormone therapy
- Pharmacy, shipping, or supply chain delays beyond clinic control
- Limitations inherent to telehealth
- Failure to disclose accurate medical history
- Failure to follow medical advice or monitoring
- Any known or unknown side effects or complications
- Lack of expected results or dissatisfaction
- Except in cases of gross negligence or willful misconduct
PATIENT ACKNOWLEDGMENTS
By signing below, I acknowledge and agree:
- I have read and understand this consent form.
- All my questions have been answered to my satisfaction.
- I understand the risks, benefits and limitations of this therapy
- I understand the elective nature of this treatment and have made an informed decision to proceed.
- While many individuals experience meaningful benefits, individual responses vary, and outcomes cannot be guaranteed.
- I understand this is not an FDA-approved treatment and involves off-label compounded medications.
- I understand prescriptions may take 10–14 business days, and delays may occur.
- I understand all appointments are via telehealth, and I accept telehealth limitations.
- I understand services are only for Arizona male residents and must be done while physically in Arizona.
- I understand other non-hormonal treatment options were discussed.
- I will inform my primary care provider, urologist, and other healthcare providers of this treatment.
- I will maintain routine medical care, including prostate screening and PSA monitoring.
- I understand I may stop therapy at any time, but no refunds will be provided for services or medications already supplied.
- I voluntarily consent to this elective treatment, accepting all outlined risks and responsibilities.
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