The Testosterone Formula is a customized prescription blend of testosterone that targets the main symptoms of hypogonadism. It can be customized into an odorless gel typically applied once daily to a small area of the upper arm and shoulder area.
What is the Testosterone Formula?
The topical Testosterone Formula combines prescription ingredients in a proprietary base developed specifically to deliver ingredients through the skin. It uses a unique delivery system designed to improve the solubility of hormones, and has been shown to increase the permeation of those molecules into and through the skin. The Testosterone Formula is specifically made without fragrance, or gluten.
Topical vs. Oral
Topical applications are known to have a lower-side effect profile when compared with systemic administration. Because the drugs are being applied directly to the skin, there is no first-pass metabolism by the liver. As a result, lower doses of the drugs may be used to get the intended response compared to the oral route. Research has shown topical application may reduce the risk of serious gastrointestinal, renal and cardiovascular adverse events compared with oral treatment options. However, you should always discuss the benefit to risk ratio with your healthcare prescriber.
Anastrozole is an aromatase inhibitor that has been shown to improve testosterone levels in adult men. Aromatase inhibitors block the conversion of testosterone into estrogen and are sometimes used to lower estrogen levels in men who receive testosterone treatment.
In men, clomiphene works by stimulating the body's own production of testosterone, signaling the testes to produce testosterone and thereby increase testosterone levels.
Testosterone is naturally produced in the male body and declines with age. Topically applied testosterone has been shown to increase serum levels in hypogonadal men to within the normal range. Research has also shown topical testosterone replacement has significantly improved sexual desire, frequency of sex, receptivity, and initiation of sexual desire in men.
Frequently asked questions
What is a compounded medication?
One size doesn’t fit all and every patient is unique. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient by a pharmacist as the result of a practitioner’s prescription drug order. While compounded medications are not FDA-approved, they serve an important patient need—especially when FDA-approved medication is not available for treatment. Our formulations are made to order in small batches to ensure freshness. The specific ingredients in your compounded formula will depend on your specific concerns and goals. It should be understood that your personal healthcare practitioner will make the final decision.
Are compounded medications FSA & HSA eligible?
Yes! All of our compounded formulations, regardless of ingredients, are eligible for Flexible Spending Accounts (FSA) and Health Saving Accounts (HSA).
What is hypogonadism?
Male hypogonadism is a condition in which the body doesn't produce enough of the hormone that plays a key role in masculine growth and development during puberty (testosterone) or enough sperm or both. You can be born with male hypogonadism, or it can develop later in life, often from injury or infection. Some types of male hypogonadism can be treated with testosterone replacement therapy. In adult males, hypogonadism can alter certain masculine physical characteristics and impair normal reproductive function. Early signs and symptoms might include: decreased sex drive, decreased energy, and/or depression
Over time, men with hypogonadism can develop:
Decrease in hair growth on the face and body
Decrease in muscle mass
Development of breast tissue (gynecomastia)
Loss of bone mass (osteoporosis)
How common is hypogonadism?
Hypogonadism affects an estimated 4 to 5 million men in the United States, and although it may occur in men at any age, low testosterone levels are especially common in older males. More than 60% of men over age 65 have free testosterone levels below the normal values of men aged 30 to 35. Studies suggest that hypogonadism in adult men is often underdiagnosed and undertreated. This may be because the symptoms are easily attributed to aging or other medical causes, or ignored by patients and physicians. In fact, only about 5% of hypogonadal men receive testosterone replacement.
What hormone levels do I need to get tested?
The only way to know if your hormones are in balance is to test them. You can either have your hormone levels tested at your next office visit or order an at-home test. We recommend having the following hormone levels tested:
Different Testing Methodologies
Serum Testing is a broadly accepted method for measuring hormones and other analytes that circulate in the bloodstream.
· Assessing total circulating endogenous hormone levels (free plus protein-bound)
· Monitoring hormone replacement therapy (sublingual, patch, pellet)
· Assessing thyroid health
· Assessing analytes that cannot be determined in dried blood spot, e.g., ferritin
Not suitable for:
· Monitoring topical hormone replacement therapy (underestimates tissue uptake)
Dried Blood Spot Testing is ideal for measuring hormones and other analytes such as insulin, blood lipids, Vitamin D, thyroid hormones, and elements like lead and magnesium. Blood spot testing gives results equivalent to serum but with distinct advantages over serum testing for monitoring topical and vaginal hormone supplementation.
· Assessing total circulating hormone levels (free plus protein-bound)
· Patients with dry mouth and/or children who may have difficulty collecting saliva
· Monitoring hormone replacement therapy (oral, sublingual, pellet)
· Assessing thyroid health, fertility parameters, and cardiometabolic risk factors
· Self-collection of sample at home at a time convenient to the patient and avoiding a trip to the phlebotomist
Saliva Testing identifies bioavailable hormone levels – the active quantity that's free to move into body tissue.
· Assessing “free” (unbound to carrier proteins) hormone levels
· Monitoring hormone replacement given orally, topically, vaginally or via pellets
· Collecting multiple samples during a day, e.g., determining diurnal cortisol levels for adrenal stress assessment
Not suitable for:
· Monitoring sublingual/troche hormone replacement
· Patients with dry mouth, e.g., due to Sjögren’s Syndrome
Is the Testosterone Formula a hormone replacement therapy (HRT)?
Yes, the Testosterone Formula is a once daily topical gel that may contain a customized blend of testosterone. The hormones used in the Testosterone Formula are structurally identical to the hormones your body produces naturally. HRT is a regimen aimed at relieving the symptoms that some men experience during hypogonadism. HRT works by replacing the hormones that your body stops producing when you go through hypogonadism or when you have had surgery to remove your testicles.
When should I see improvement in my symptoms?
Based on research and patient testimonials, it usually takes 2 to 3 weeks before you will feel the initial benefits and up to 6 weeks to feel the full effects; however, each patient is unique and time frames may differ. It may also take your body time to get used to it.
How should I use the Testosterone Formula?
The Testosterone Formula is for topical use only. If this medicine gets in your eyes or mouth, rinse with water. Do not apply this medication to your eyelids.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Wash your hands with soap and water before and after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.
Apply 1 dose to a small area of the upper arm and shoulder area once daily at the same time each morning (rotating between the right and left side each day).
Should be applied after showering or bathing to clean, dry, intact skin.
Let dry completely before dressing. Wait at least 2 hours before bathing or swimming.
Do not allow a child to come into contact with the skin where you have applied testosterone topically. Topical testosterone is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.
Do not cover treated skin with a bandage. Bandaging can increase the amount of drug absorbed through your skin and may cause harmful effects.
Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.
If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using testosterone
Who should not use the Testosterone Formula?
Do not start using the Testosterone Formula if you:
Currently have or have had breast cancer or prostate cancer
Testosterone may increase the chance of getting certain types of cancer, including cancer of the breast or prostate. If you have or have had cancer, talk with your healthcare provider about whether you should use the Testosterone Formula.
Had a stroke or heart attack
Testosterone should not be used to prevent heart disease, stroke, or dementia.
Currently have or have had blood clots
Have been diagnosed with a bleeding disorder
Have a hypersensitivity to any of the ingredients prescribed
The Testosterone Formula is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use the Testosterone Formula if the test is positive and talk to your healthcare provider
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.
How should I store this medication?
Store at room temperature away from moisture and heat between 68°F to 77°F (20°C to 25°C).
Research has shown, topically applied medications are less likely to cause the same systemic side effects or drug-to-drug interactions as oral medications; however, there is never an absolute zero chance that side effects or drug interactions will not occur. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.
What should I avoid while using the Testosterone Formula?
Avoid getting this medicine in your eyes. If this does happen, rinse with water.
Wait at least 25 minutes after applying topical testosterone before you apply sunscreen to the same skin area.
Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using testosterone.
Avoid applying testosterone to your penis or scrotum.
Avoid using other products that may contain testosterone unless discussed with your doctor.
What are the common side effects of the Testosterone Formula?
Less serious, but common side effects include:
Redness, itching, burning, or other irritation at the application site
Increased prostate specific antigen
Fluid retention and swelling
Acne, increased hair growth, voice changes
High blood pressure
Increased red blood cell count
Nausea and vomiting
Frequent or prolonged erections
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
Enlargement of your prostate gland
Serious, but less common side effects include:
High blood pressure
Enlarged or painful breasts
Having problems breathing while you sleep (sleep apnea)
These are not all of the possible side effects of the Testosterone Formula. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Ferri FF. Hypogonadism, male. In: Ferri's Clinical Advisor 2020. Elsevier; 2020. https://www.clinicalkey.com. Accessed Aug. 13, 2019.
Snyder PJ. Clinical features and diagnosis of male hypogonadism. https://www.uptodate.com/contents/search. Accessed Aug. 13, 2019.
AskMayoExpert. Male hypogonadism (adult). Mayo Clinic; 2018.
Snyder PJ. Testosterone treatment of male hypogonadism. https://www.uptodate.com/contents/search. Accessed Aug. 13, 2019.
AskMayoExpert. Delayed male puberty (child). Mayo Clinic; 2019.
Sargis RM, et al. Evaluation and treatment of male hypogonadism. Journal of the American Medical Association. 2018; doi:10.1001/jama.2018.3182.
Gardner DG, et al., eds. Testes. In: Greenspan's Basic and Clinical Endocrinology. 10th ed. McGraw-Hill Education; 2018. https://accessmedicine.mhmedical.com. Accessed Aug. 13, 2019.
Male hypogonadism. Merck Manual Professional Version. https://www.merckmanuals.com/professional/genitourinary-disorders/male-reproductive-endocrinology-and-related-disorders/male-hypogonadism#. Accessed Aug. 13, 2019.
FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-oral-testosterone-capsule-treatment-men-certain-forms-hypogonadism. Accessed Sept. 26, 2019.
Bhasin S, et al. Testosterone therapy in men with hypogonadism: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism. 2018;103:1715.
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