TestoCreme Study

CLINICAL TRIALS HAVE BEEN COMPLETED AND ARE AVAILABLE FOR ANY PHYSICIAN REQUESTING INFORMATION ABOUT OUR CUSTOM COMPOUNDED  TESTOCREME® (DrK formula) , PATENTED.

INTRODUCTION

Testosterone is a Class 111 medication, as classified by the FDA. All topical transdermal testosterone products (eg. AndroGel, AndroDerm, Testim and Testocreme) contain USP soy based testosterone which is approved by the FDA. Testocreme® contains 100 mg of bioidentical USP Testosterone in each gram of cream. The modified pluronic lecithin organogel has been patented and simply acts as the carrier base.

PRESCRIBING TESTOSTERONE PRODUCTS

The AACE guidelines recommend that prior to prescribing any testosterone product, the following tests should be performed.

1. Free and Total Testosterone by equilibrium dialysis

2. Sex Hormone Binding Globulin or SHBG

3. Prostate Specific Antigen or PSA

4. Comprehensive metabolic profile including liver enzymes

5. Complete blood count or  CBC and differential

*American Academy of Clinical Endocrinologists  AACE

HOW TO ORDER TESTOCREME® (K) FOR YOUR PATIENT

Any physician in the USA can prescribe Testocreme® by sending a duplicate prescription to Central Avenue Pharmacy by fax or contacting pharmacist Dana Gordon at dana@caprx.com . The phone number is 831-373-1225.

MONITORING TESTOSTERONE REPALCEMENT THERAPY or TRT.

If a physician prescribes testosterone products, he/she should monitor levels of free testosterone (FT) and total testosterone (TT) and SHBG every one to three months until stable blood levels are reached.  Liver enzymes, PSA and CBC should be performed every six months .  Blood should be withdrawn approximately 12 hours after last application of hormone in order to obtain "steady state" levels.

PATIENT  TESTING AND MONITORING

Patients must have some tests performed that require at least two visits to the doctor's office to determine their baseline testosterone level and review the results before TRT is begun.

Patients must tell their doctor if they are taking any drugs in addition to those prescribed. This includes
prescription drugs and nonprescription (over the counter) medications.Within the last three months prior to evaluation, patients cannot take any prescription (sex) steroids.

Patients also should not be taking gonadotrophins, antipsychotic therapy drugs, narcotic analgesics, oral anticoagulants (blood thinning drugs), cyclosporine, oxyphenbutazone, glucocorticoids, mineralcorticoids, hydantoins, primidone, rifampicin, barbiturates, carbamazepine, or antifungal drugs including griseofulvin.

If a patient is taking medications, other than those not allowed above, they must be stable on a current dose for at least three months. Patients must not give their medication to anyone else, or use any illegal (street) drugs.

At the first visit (Initial Screening), the following events will happen:

You will be asked several questions that will determine if you need TRT. Some of these are about your medical history and others are more general, for example, your date of birth and alcohol consumption.

You will be asked about all medicines that you have been taking within the last 90 days including: prescription medicines, medicines that do not require a prescription and illegal drugs.

You will be asked about any medical conditions or symptoms you have experienced recently; You will have your blood pressure, heart rate, height and weight measured; You will have a prostate examination (digital rectal); Blood samples will be taken (about 2 teaspoons of blood) for routine laboratory tests and for a PSA (prostate specific antigen) test; You will be asked to provide a urine sample for routine lab tests; You will have a physical including an examination of your genitals.

If you have been newly diagnosed as having low testosterone or hypogonadism and have never been on any kind of testosterone replacement therapy, then you will have all Initial and Baseline Screening assessments performed and you will have blood samples drawn for routine laboratory tests.

If your serum total and free testosterone level obtained from the first Baseline Screening Visit were NOT within the normal or designated range, you will be given a prescription for a testosteorne product. If your levels are within the designated range you will be asked to make another appointment for further blood testing.

Further testing includes:

1. Dihydrotestosterone or DHT levels

2. Estradiol or E2 levels or even total estrogens

3. Luteinizing Hormone or LH and

4. Follicle Stimulating Hormone or FSH.

At your third visit to the doctor, the following events will happen:
You will have blood drawn (about 2 teaspoons) between 6:00 am to 10:00am for pharmacokinetic and endocrine (relating to hormones) assessments, before you take your morning dose of testosterone; to confirm the serum total and free testosterone levels as compared to those obtained in the first test,following treatment ; You will probably have your blood pressure, heart rate and body weight measured; You may be asked to provide a urine sample for routine lab tests.

RISKS AND DISCOMFORTS

It has been explained to you that the following are the risks and
discomforts, which may be expected during the trial period. All drugs have the potential to cause some side effects and with any relatively new drug there may be unknown side effects. Sometimes during the course of TRT  men can develop difficulty urinating, increased acne or a rash. If this happens, your doctor wants to know and will discuss with you whether you want to continue or try a different medication.

Common side effects caused by testosterone may include the following: nausea, headache, depression, acne, increased sex drive, painful and prolonged erection, edema (swelling), increased serum cholesterol, changes in liver function and an increase in red blood cell count (erythrocytosis).

Long term testosterone use in elderly men may cause an increased risk of prostate growth, cancer of the prostate, or breast enlargement. Some men may experience discomfort from the pressure applied during the digital rectal exam. Possible side effects from blood drawing include faintness, swelling of the vein, pain, bruising or bleeding at the site of puncture. There is also a slight possibility of infection at the site where blood was drawn.

UNFORESEEN RISKS

There is a chance that an allergic reaction to any medication or drug may occur such as skin rash, fever or possibly, if not treated promptly, more serious problems such as breathing difficulties or shock can develop. It is not possible to predict in advance if any of these problems will develop.

POTENTIAL BENEFITS

A Natural Testosterone Replacement Therapy For Men

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