Feel Young Again Today, P.C. Dba Vestavia Hills Internal Medicine Dr. Nadeem Akhtar Date: Patient Name: Chart Number: Bio Identical Hormone Therapy Female Estradiol and Testosterone Hormone Insertion Consent Form Hormone replacement therapy is indicated for treatment of menopausal symptoms. Estrogen therapy can alleviate mood swings, anxiety and irritability and other symptoms of menopausal symptoms. Estrogen therapy can alleviate mood swings, anxiety, irritability, hot flashes, and other symptoms of menopause. Testosterone can increase energy, libido, and sense of well being. I may also see a decrease in the severity and frequency of my headaches. Bio identical Pellets off me an additional option of how these bio-identical hormones are delivered. Other options include using bio-identical creams that can be mixed by a pharmacist after a physician writes a prescription. I recognize that this is not the usual and customary means of hormone replacement. I have been told that I am to have bio-identical hormone Estradiol and testosterone inserted under my skin to achieve a steady delivery of natural Estradiol and testosterone hormone in my body. I recognize that estrogen replacement therapy increases the risk of breast and ovarian cancer. In patients with an intact uterus, progesterone replacement therapy (either continuous or intermittent) is also prescribed, as estrogen therapy alone increases the risk of uterine cancer. Higher cardiovascular risk is now recognized with this replacement therapy. I can choose to tolerate and continue to live with the symptoms of menopause, or choose to get replacement therapy with either synthetic estrogens by mouth, trans dermal, or bio identical subcutaneous placement of Estradiol pellets. The risk with bio identical replacement therapy is to be considered the same as synthetic hormone replacement therapy. No claim of any decrease in side effects is being made. In addition, there is an additional risk of scar formation, bleeding, and infection from subcutaneous pellet insertion. Testosterone therapy has not been approved by the FDA for women. Whenever testosterone therapy is prescribed for women it is considered an off label use of testosterone. Potential side effects of androgen therapy include acne, adverse lipid changes, permanent lowering of voice, excess facial and body hair, and emotional changes (e.g. increased anger). Clinical trial data shows these side effects to be infrequent if androgen levels are maintained within normal a physiological range. Lowered HDL cholesterol, increased hematocrit levels, and abnormal liver function tests have been reported with certain ORAL testosterone preparations. Princeton Consensus statement on the definition, classification, and assessment on Female Androgen insufficiency published in Fertility and Serility Volume 77, NO. 4 April 2002 has proposed the definition of androgen (testosterone) insufficiency in women based on three essential criteria. First, clinical symptoms of androgen insufficiency should be clearly present. Symptoms include a diminished sense of well being or dysphonic mood, persistent unexplained fatigue, and sexual function changes including decreased libido as well as sexual receptivity and pleasure. Vasomotor instability or decreased lubrication have been observed in some studies, even in women who are adequately estrogenized. Other potential sign and symptoms include bone loss, decreased muscle strength, and changes in cognition or memory. Second, since estrogen effects are also strongly linked to mood, psychological well being, and sexual function in women, a diagnosis of androgen insufficiency should only be made in women who are adequately estrogenized. Third, free testosterone levels should be at or below the lowest quartiles of reproductive ages, 20-40. Although this therapy has been approved for human use, there are few doctors who currently administer estradiol and testosterone pellets in the United States. I realize that this is not the usual and customary means of hormone replacement. I have been told I am to have bio-identical hormonal testosterone inserted under my skin to achieve a steady delivery of natural testosterone hormone into my blood system. I realize that testosterone can increase my energy, my libido, and my sense of wellbeing. I may also see testosterone decreasing the frequency and severity of my headaches. I have also been told that I am to have bio-identical hormonal estrogen inserted under my skin to also achieve a steady state of estrogen in my body. I realize that estrogen can eliminate my mood swings, anxiety, and irritability. I realize that in the past, ale athletes have abused testosterone by taking huge quantities of synthetic testosterone, and by doing so may have incurred heart problems and elevated cholesterol. However, low-dose, non-oral, natural testosterone that is used in bio-identical hormonal therapy has NOT been associated with these problems. I understand there is a change, depending on the number of bio-identical hormonal therapy pellets I am to receive. As this procedure is an expense often not covered by insurance benefits, I understand payment is due in full at the time of service. If this is an initial bio-identical hormone therapy insertion, I understand that my insurance will be billed as a courtesy, to establish whether or not my insurance will pay for the procedure. I will be refunded in the event my insurance pays. My insurance will be billed for subsequent insertions without requiring prepayments unless this is the beginning of a new year, and/or my insurance company/plan has changed. I acknowledge that I have read the above and have been encouraged to ask any questions regarding hormone replacement therapy in general and bio identical hormone replacement therapy (including pellet insertion). My questions have been answered to my satisfaction. _______________________________________________________ ___________________________ Patient Signature Date