DESCRIPTION OF TREATMENT
I am being offered oral bioidentical hormone therapy (BHRT), designed specifically for women, 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 women may include:
- Progesterone (oral tablet)
- Estradiol/Estriol (Estrogen, oral tablet)
- Testosterone (oral tablet, off-label use for women)
- DHEA (dehydroepiandrosterone, oral tablet)
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 women experience symptoms of menopause or perimenopause — such as hot flashes, night sweats, mood changes, sleep disturbances, vaginal dryness, low libido, or low 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 women 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 female 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 PROGESTERONE THERAPY
Possible benefits may include:
- Supporting uterine lining health
- Balancing estrogen’s effects on the uterus
- Supporting sleep quality
- Calming mood or reducing irritability
- May help regulating menstrual cycles
- Supporting bone health
Possible risks and side effects may include:
- Breast tenderness
- Bloating or fluid retention
- Mood changes, drowsiness, or dizziness
- Headaches
- Acne
- Rare: hormone-sensitive tissue stimulation
ABOUT ESTROGEN THERAPY
Possible benefits may include:
- Reducing hot flashes, night sweats
- Relieving vaginal dryness or discomfort
- Supporting bone density
- Helping skin elasticity
- Supporting urinary health
- Supporting cognitive function and mood
- Improving sleep quality
Possible risks and side effects may include:
- Breast tenderness or swelling
- Vaginal bleeding or spotting
- Bloating, fluid retention, or weight changes
- Mood changes, headaches, or migraines
- Blood clots, stroke, heart attack (rare)
- Hormone-sensitive tissue stimulation, potential to worsen hormone-sensitive cancers (rare but serious)
ABOUT TESTOSTERONE THERAPY (Off-label use in women)
Possible benefits may include:
- Supporting libido and sexual function
- Helping maintain muscle mass
- Supporting energy and stamina
- Supporting mood or motivation
- 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 unwanted facial/body hair
- Mood changes, irritability, or aggression (rare)
- Voice deepening (rare, usually dose-related)
- Clitoral enlargement (rare, usually dose-related)
- Hormone-sensitive tissue stimulation (rare but serious)
ABOUT DHEA THERAPY (For women)
Possible benefits may include:
- Supporting ,focus, mood and sense of well-being
- Helping with mild vaginal atrophy or dryness
- Supporting bone health
- Supporting energy and stamina
- Potential support in some fertility cases (only under medical supervision)
Possible risks and side effects may include:
- Acne or oily skin
- Unwanted facial/body hair growth
- Hair thinning
- Breast tenderness
- Mood changes or irritability
- Hormone-sensitive tissue stimulation (rare but serious)
- Not recommended for women with a current or past history of breast, uterine, ovarian, or other hormone-related cancers
OTHER OPTIONS DISCUSSED
I understand alternatives to compounded BHRT include:
- FDA-approved commercial hormone therapies
- 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 women of childbearing age unless reliable contraception is in use and risks are fully discussed.
- Estrogen, DHEA, testosterone, or progesterone therapy must not be used if I have a current or past history of breast, uterine, ovarian, or any other hormone-related cancer.
- 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:
- Breast tenderness, swelling
- Vaginal bleeding or spotting
- Mood changes, anxiety, depression
- Headaches, migraines
- Weight gain or body composition changes
- Bloating, fluid retention
- Acne, hair thinning or hair growth
- Changes in liver function (such as elevated liver enzymes; liver toxicity or damage is rare)
- Uterine or endometrial changes
- Blood clots, stroke, heart attack (rare)
- Hormone-sensitive tissue stimulation, potential to worsen hormone-sensitive cancers (rare but serious)
CONTRAINDICATIONS
I confirm I have disclosed if I have or have had:
- Current or past breast cancer, uterine cancer, ovarian cancer, or any other hormone-related cancer
- Stroke, heart attack, or blood clots
- Active liver disease or abnormal liver function
- Unexplained vaginal bleeding
- Pregnancy or plans to conceive
- Lack of reliable contraception (if of childbearing age)
- Severe, uncontrolled hypertension or cardiovascular disease
- Allergies to hormone or compound ingredients
ONGOING MEDICAL CARE & CHECKUPS
I understand:
- I must maintain care with my primary care physician (PCP), OB/GYN, and specialists.
- I am responsible for routine women’s health screenings, including Pap smears, pelvic exams, and mammograms.
- This therapy does not replace standard cancer screening or gynecologic 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 PCP, OB/GYN, urgent care, or emergency services when needed.
- EMERGENCY CARE NOTICE: 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 female residents and must be done while physically in Arizona.
- I understand other non-hormonal treatment options were discussed.
- I will inform my PCP, OB/GYN, and other healthcare providers of this treatment.
- I will maintain routine medical care, including Pap smears and mammograms.
- I understand hormone therapy in childbearing age requires contraception and medical discussion.
- 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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