Wiley Protocol Consent

Wiley Protocol Consent Form

INFORMED CONSENT FOR TAKING NON-FDA APPROVED DOSES OF FDA APPROVED HORMONE REPLACEMENT THERAPY FOR MENOPAUSE SYMPTOMS

I request and consent to treatment with

Wiley Protocol  Estradiol ____,Wiley Protocol Progesterone ____,

Wiley Protocol Testosterone ____,Wiley Protocol Thyroid ____,

Wiley Protocol for Men ____, and/orWiley Protocol Face Creme ____

(please mark check box and initial) for the purpose of correcting hormone deficiencies and imbalances. I understand that initial blood tests may be performed to rule out any conditions that would disqualify me from the program, require any prior treatment before starting the program, or closer monitoring during the program.

Potential Side Effects and Risks

Properly prescribed, properly dosed, and properly monitored bioidentical hormone replacement therapy is virtually free of negative side effects, but because individual variability and sensitivity to hormones patients may experience certain symptoms.

With any drug there is the possibility of an allergic reaction or unusual reaction that may cause a skin rash, difficulty breathing, collapse, or even death.

I agree to immediately report any problems that might occur to Dr. Comeaux during the treatment program. I further understand that there could be risks involved as there are with all medications and that not complying with the dosage recommendations and other treatment recommendations could increase risks and alter the results.

Monitoring and Follow Up

I understand that the Wiley Protocol will be prescribed and monitored by Dr. Comeaux.

I agree to the following:

  • A comprehensive review of my medical history and thorough physical examination.
  • Laboratory testing as recommended by Dr. Comeaux.
  • To read the book Sex, Lies, and Menopause by T.S. Wiley.
  • To monitor and document my symptoms on the Wiley Protocol Lunar or Personal Calendar as applicable.
  • To report any of the following immediately by e-mail AND telephone: worsening signs and symptoms, and any unexplained complaints and potential side effects.
  • To follow up in the office at least once every three to six weeks, or more often, depending on the patient’s needs.
  • To comply with Dr. Comeaux’s dietary, lifestyle, and treatment recommendations.
  • To follow Dr. Comeaux’s instructions for monitoring any other parameters such as blood pressure, pulse, serum glucose levels, and laboratory testing, as applicable to the patient’s medical condition.Women Must Stop Treatment When PregnantNotice to all pregnant women: All female patients must alert Dr. Comeaux immediately if they know or suspect that they are pregnant.No Guarantee of Results

    I understand that results may vary and once I have begun the protocol I am committed to following through.

    I understand that the protocol and the hormones may involve risk. I understand that there are no refunds, returns or store credit for hormones, nutritional supplements, or medical consultations. There is no weight loss guarantee with this program. I have read and understand the information given to me about the hormones. I have asked and had answered

Please initial after reading this page _____

Any questions that I may have after reading this form. I understand the possible side-effects and agree to advise Dr. Comeaux’s office should they occur. I understand that I may quit the protocol at any time. I agree to stop the protocol if I become pregnant and agree to advise Dr. Comeaux’s office should I decide to become pregnant. No adverse side effects or complications are expected, but in the event that an illness does occur, I understand that I need to contact the office. Dr. Comeaux is serving as your consultant, not your primary care physician, during the course of this protocol. If I experience an emergency situation, I understand that I need to go to an emergency facility.

I realize that Dr. Comeaux cannot offer any absolute guarantees to me regarding cure or improvement of my condition. I understand that I am free to withdraw my consent and discontinue treatment at any time.

By signing below, I understand that I am agreeing to take FDA approved hormones for the treatment of menopausal symptoms. I have been fully informed that the doses I am agreeing to take are not FDA approved for the treatment of menopausal symptoms.

I am aware that there may be benefit of these doses as noted in the book, Sex, Lies and Menopause, by T. S. Wiley, Julie Taguchi, M.D. and Bent Formby, PH.D. However, I have been fully informed of the potential risks of these different hormone replacement doses. I understand that there are no clinical trials on these doses and that they may cause harm.

I am aware that the Women’s Health Initiative Study found that “hormone replacement therapy” (of non bio-identical synthetics) for long term use after menopause may cause harm. This harm could include heart attacks, dementia, strokes, breast cancer, blood clots, pulmonary embolism (blood clots to the lungs), gall bladder attacks, and even sudden death.

By signing below, I agree that I have been fully informed of my potential risks and benefits. I consent to take these non- FDA approved doses of hormone and agree to be closely monitored. This is my freedom of choice for my healthcare.

YOUR SIGNATURE BELOW INDICATES THAT YOU HAVE READ THE INFORMATION ABOVE, HAVE HAD YOUR QUESTIONS ANSWERED, HAVE HAD POTENTIAL SIDE EFFECTS EXPLAINED, AND AGREE TO NOTIFY DR. Comeaux’S OFFICE OF ANY CHANGE IN YOUR HEALTH STATUS OR MEDICATIONS PRESCRIBED.
I CERTIFY THAT I UNDERSTAND THE PROTOCOL AND I WILL FOLLOW IT STRICTLY.

Signed:

Patient Name: Parent, Legal Guardian, or Caregiver

_____________________________________________________ Date: ___________________