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Pellet Hormone Replacement Therapy

Overview

Testosterone -The Heart Hormone for Men DVD

Male Testosterone Pellet Insertion Consent Form and Post-Implant Instructions

Testopel® Pellet Testosterone Replacement Therapy

Female Pellet Estradiol and Testosterone Consent Form and Post-Implant Instructions

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Overview

The ideal approach to hormone replacement therapy must:
A. Provide steady levels of bioidentical hormones (mimicking normal gonadal function as closely as possible).
B. Be of reasonable cost.
C. Be easy to apply.
D. Be as safe as hormone replacement therapy can possibly be.

As a young doctor, before I knew better, I actually prescribed the orally available forms of Estrogen (Conjugated Equine Estrogens) and Progesterone (Provera).  These are not normal human molecules; the chemical groups added to allow oral absorption of these agents adds greatly to their toxicity.  Provera can cause vasoconstriction and should never be used.  While many patients have done well on CEE (and CEE has been shown to be of value in women with atherosclerosis and elevated Lp(a) levels), at this time it makes little sense to me to start a patient on CEE, now that we have low cost and lower risk bioidentical preparations available.  There can be down sides to any form of HRT, but it is important to understand that the significant risks that have been associated with CEE and Provera do not necessarily apply to the bioidentical forms. 

Testosterone in men can be administered as a topical cream, gel, or patch, but in my experience it is very difficult to obtain and maintain a physiologic testosterone level with these agents (and the prescription forms are quite expensive.  Intramuscular injections of testosterone ester will raise the testosterone level, but in a saw tooth fashion, with a supraphysiologic (well above the desirable range) peak 1-2 days after the injection, followed by a subphysiologic (below normal) trough level prior to the next injection.  When supraphysiologic, testosterone is more readily converted in to estradiol (exactly what you do not want, as an elevated estradiol is associated with increased vascular disease progression) and in to dihydrotestosterone (DHT - which cause prostate enlargement).

In our experience, the most effective forms of testosterone replacement therapy involves the placement of pellets of crystallized, bioidentical testosterone into the subcutaneous fat over the buttocks.  The pellets dissolve slowly, providing a reasonably steady level of testosterone, maintained within the desirable range over at least 4 and usually 6 months.  The supraphysiologic peak levels that encourage conversion of testosterone into estradiol and DHT are eliminated.  Insurance and Medicare typically cover the cost of pellet placement.  Over the past five years we have been using SottoPelle compounded pellets, the cost of which is typically not covered by insurance, and now Testopel pellets, which are FDA approved and thus typically covered by commercial insurance prescription plans.  The consent forms below discuss their use.  We also provide pellet estradiol and testosterone (at a lower dose than in men) replacement therapy to women; here again we can achieve stable blood levels (and as we bypass the liver the CRP level does not rise as it does with all oral forms of estradiol).  Overall we feel that pellet HRT is the best approach to hormone replacement therapy and is essentially the only approach that we will utilize. 


Testosterone -The Heart Hormone for Men DVD

                  Our two DVD presentation reviews the scientific and clinical literature on Testosterone Replacement Therapy, with special emphasis on the cardiovascular benefits of Testosterone.  The studies
presented on the DVD - see Testosterone Bibliography - can be reviewed in abstract form on PubMed  (www.pubmed.com) or could be obtained via a medical library.  The DVD is available at the
office or can be ordered (click on a DVDs, CDs, and Presentations tab). 


T                                                                                                                  Male Testosterone Pellet Insertion Consent Form

The benefits of testosterone replacement therapy, particularly with respect to cardiovascular health, have been well documented (see Testosterone – The Heart Hormone for Men DVD).  Although testosterone pellets have been approved for human use, there are few doctors in the US who currently provide pellet testosterone replacement therapy.  I realize that pellet therapy is thus not the usual and customary means of prescribing testosterone.  I realize that the advantages of testosterone for men include:  a) behavioral changes such as decreased depression, anxiety, and irritability, increased energy and motivation, enhanced stamina, improved self-image and self-worth; b) improvement in cognitive function and short-term memory; c) physical effects such as decreased body fat and increased lean body mass, muscle mass, and bone density; d) sexual benefits such as increased libido and improved erectile function, and e) multiple cardiovascular benefits.

I realize there are potential concerns with testosterone therapy and they include the possibility of increasing the growth rate of pre-existent prostate cancer.  For this reason, in most patients a digital rectal exam and prostate specific antigen (PSA) blood test will be done before starting testosterone replacement and the PSA test will be carried out periodically thereafter.  If there is suspicion of possible prostate cancer, I consent to undergo an ultrasound of the prostate gland and/or to be evaluated by a urologist.  I understand that while urinary symptoms typically improve with testosterone, rarely they may worsen, or worsen before improving.

A second concern is that testosterone may increase one’s red cell count, increasing the thickness or viscosity of the blood (sleep apnea, advanced lung disease, and the blood disorder polycythemia vera may also increase the red cell count).  This problem can be diagnosed with a blood test (Hb & Hct), and then addressed through donating blood periodically.  Thus, your Hb & Hct. will be checked periodically, typically once a year.

As with any form of implant therapy, there is always the risk (small but not nonexistent) of infection, bruising, or bleeding at the insertion site.  I agree to follow the instructions on the post-pellet recommendation sheet.

The final concern, especially in younger men, is the testosterone administration can suppress the development of sperm and the sperm count could fall while a person is on treatment.  However, to date, this appears to be a reversible process and once testosterone is discontinued, the sperm count is restored.  Men who are concerned regarding future fertility are encouraged to have a semen analysis carried out prior to the initiation of testosterone therapy.  Testosterone administration is not to be used as a form of male contraception.

My signature certifies I have read the above and acknowledge I have been encouraged to ask any questions regarding testosterone pellets.  I have or will review the Testosterone DVD or have been offered the opportunity to do so.  My questions have been answered to my satisfaction.

  __________________________________________________      ______________________________ 
 Patient Signature                                                                                 Date

 

Male Post Implantation Instructions 

The pressure bandage can be removed in two (2) hours. You may replace it with a band-aid to catch any anesthetic that may happen to ooze out. 
            The Steri-Strip underneath should be removed in two (2) days. 

Things we ask you NOT to do:
            • Do not take tub baths for seven (7) days.
            • Get into a hot tub or swimming pool for three (3) days.
            • Do not scrub the site until the incision is well healed (about seven days.)
            • No exercise that might disturb the pellet site for three days!!
                                     Relax and take time off!!

             Things you CAN do:
             • Shower
             • Enjoy life!! 

The sodium bicarbonate in the anesthetic may cause the site to swell for 1-3 days. Do not worry - this is normal. 

The incision site may feel uncomfortable for 2-10 days.  You will be able to feel the pellets beneath your skin for several months. 

Please call if you have any bleeding (not oozing) or pus coming out of the insertion site. 

We may or may not ask you to take Keflex 500 mg twice a day for 3 days (provided that you are not allergic to Penicillin of Cephalosporin antibiotics).


Testopel® Pellet Testosterone Replacement Therapy

The benefit of Testosterone replacement therapy (TRT) in the prevention and treatment of male cardiovascular disease has been well established (see our Testosterone DVD for more information). 

The best approach to TRT is subcutaneous pellet implantation.  The pellets are the size of a grain of rice, and contain either 100 or 200 mg of crystallized bioidentical testosterone.  The pellets are implanted using sterile technique into the subcutaneous tissue over the buttocks region.  This involves a needle stick to obtain local anesthesia.  Patient discomfort is otherwise minimal.  The pellets dissolve slowly, allowing for steady, physiologic Testosterone levels, avoiding the peaks and troughs that occur with intramuscular and topical Testosterone preparations.  We have been providing pellet TRT over the past five years, using pellets compounded by Solutions Pharmacy, and have been pleased with the results.  Six to eight 200 mg pellets are typically placed every five to seven months.  Dosing adjustments are made in relation to blood levels and your clinical response.  Insurers typically cover the cost of pellet insertion, but because the pellets are compounded, they do not have a pharmaceutical billing code.  Pellet cost is typically out of pocket, around $260 every six months.  Your co-pay for the prescription topical preparations is typically a little less than this.

Slate Pharmaceuticals has come out with TestopelŇ, a FDA approved Testosterone pellet.  TestopelŇ has a billing code and likely will be covered by your insurer.  We can find out for sure.  If you are interested in TestopelŇ therapy and if we feel that pellet Testosterone is appropriate for your medical condition, then a script is faxed to a specific pharmacy (Medicine Shoppe in Piqua, Ohio).  They will certify coverage through your insurer and will contact you with an exact co-pay amount.  If this is acceptable to you, then the pellets will be shipped to our office.  We will then contact you and arrange for pellet placement and any follow-up labs that we might need.  Within this format there is no guess work.  You know your co-pay up front and can thus make an informed decision.

If you are scheduled to receive pellet TRT using the Solutions pellets and wish to be switched over to TestopelŇ, please let us know and we will initiate the necessary paperwork.  This gives you another option as to how you want your health care to be delivered to you – these are your choices.

                                                                                                                                                                                                     James C. Roberts MD FACC  11/26/09  


 Female Pellet Estradiol and Testosterone Consent Form and Post-Implant Instructions

 Although pellets have 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 understand that one to two compounded testosterone 75 mg or 100 mg pellets will be placed subcutaneously to provide a steady delivery of natural testosterone hormone into my circulation. I realize that testosterone can increase my energy, my libido, and increase my sense of well-being. I will also likely receive one or two compounded estradiol pellets, again aiming to achieve a steady blood level of the hormone estradiol.  My expectation is that symptoms related to menopausal hormone decline (hot flashes, night sweats, mood swings) will improve, as may the frequency and severity of estradiol deficiency related headache.  I understand that bio-identical estradiol replacement therapy has been associated with a reduction in the rate of soft plaque progression (evidenced by a reduction in carotid intima-media thickening), while the effects of non-bioidentical replacement therapy, as reported in the literature to date, have been mixed. 

 I realize that hormone replacement therapy is never without risk, but that we feel that the risks associated with bioidentical hormone replacement are likely less than those associated with non-bioidentical agents (which contain non-human components designed to render them orally absorbable).  I agree to undergo periodic evaluations of breast and reproductive organ health by my Ob-Gyn or primary care provider to monitor for any abnormalities in these regions.  I agree to consider the concomitant use of nutritional supplements felt to reduce one’s risk of adverse biochemical effects of hormone replacement therapy (i.e. calcium-D-glucarate, red wine extract, diindolemethane, alone or in combination – discussed in Avoiding Breast Cancer While Balancing Your Hormones by Joseph F. McWherter MD and David Brownstein MD).  I understand that oral Progesterone replacement (Promethium® or compounded micronized bio-identical progesterone) will be necessary if my uterus is still in place (to prevent unopposed proliferation of the endometrial tissues with subsequent breakthrough bleeding).  I understand that in the past, male athletes have abused testosterone. When they took huge quantities of oral synthetic testosterone, they may have incurred heart problems and elevated cholesterol.  However, low-dose, non-oral, natural testosterone pellets have not been associated with these problems.

I understand there is a charge (approximately $150.00 for the pellets, not covered by insurance) plus a charge for the pellet placement procedure (usually covered by insurance) and any additional evaluation and management services provided during my visit (usually covered by insurance), the precise amount to be determined by comprehensive Heart Care.  

My signature certifies that I have read the above and acknowledge that I have been encouraged to ask any questions regarding pellet hormone replacement therapy.  My questions have been answered to my satisfaction and I consent to pellet placement.

 _______________________________________               ____________________________
Patient Signature                                                                     Date

 

Female Post-Implant Instructions

Remove the pressure bandage in two (2) hours. You may replace it with a band-aid to catch any anesthetic that my ooze out.
The Steri-Strip underneath should be removed in two (2) days. 

Do not take tub baths; get into a hot tub or swimming pool for three (3) days. You may shower, but do not scrub the site until the incision is well healed (about seven (7) days).

The sodium bicarbonate in the anesthetic may cause the site to swell for 1-3 days. Do not worry... this is normal.

The site may be uncomfortable for 2-7 days.

Please call if you have any bleeding (not oozing) or puss coming out of the insertion site.