Commercial Brand vs. Compounded Testosterone: Which Medication Should I Take for TRT?
Testosterone
Replacement Therapy (TRT) has become an increasingly popular medical
treatment for men experiencing symptoms of low testosterone. Symptoms such as
decreased libido, fatigue, and erectile dysfunction are just a few reasons why
men decide to get tested, diagnosed and treated for what’s called male andropause
or hypogonadism. While both commercial brand and compounded testosterone
options exist, understanding their key differences is crucial for making
informed decisions about treatment and can help patients decide which options
are best for their individual needs.
Manufacturing and Quality Control
Commercial brand testosterone is produced by large
pharmaceutical companies and adheres to strict FDA regulations. The
manufacturing process involves large-scale production with automated machinery
and rigorous testing to ensure consistency, purity, potency, and safety. These
products are subject to stringent quality control measures, giving patients
confidence in their reliability.
Here are some of the large pharmaceutical companies that
manufacture testosterone:
- AbbVie:
Manufactures AndroGel,
a leading testosterone gel.
- Endo
Pharmaceuticals: Produces several testosterone products, including
Testim (gel), Fortesta (gel), and Testopel (pellets).
- Pfizer:
Manufactures Depo-Testosterone, an injectable testosterone product.
- Allergan:
Manufactures Androderm, a testosterone patch.
- Antares
Pharma: Manufactures Xyosted, an injectable testosterone product.
- Clarus
Therapeutics: Manufactures Jatenzo, an oral testosterone capsule.
- Aytu
BioScience: Manufactures Natesto, a nasal testosterone gel.
In contrast, compounded testosterone is custom-made by
licensed pharmacists in compounding pharmacies to meet individual patient
needs. While these pharmacies follow specific regulatory standards, the level
of oversight is not as rigorous as FDA-approved medications. They still have to
get their medications tested and undergo multiple state inspections from state
and other health
department regulatory agencies that oversee pharmacy safety. This
difference in regulation allows compounding pharmacies to provide greater
customization for patients.
Types of Testosterone Formulations
Commercial brands typically offer a standardized range of
formulations, including injectables (e.g., testosterone cypionate or
enanthate), gels, and patches. Examples include AndroGel, Testim, Axiron, and
Fortesta. These options are convenient but may not suit all patients' unique
needs
Compounded testosterone provides more flexibility in
formulation. Some patients may respond better to one form over the other, a
different strength or even a specific ester such as cottonseed or grapeseed oil
for example. A compounding pharmacy can produce a product that is patient specific
which allows for more customized personal protocols for patients who are
looking for the
best testosterone to take for TRT.
Options include:
- Injectables:
Customizable esters (e.g., cypionate, enanthate, or propionate) and oils
(e.g., sesame or grapeseed oil) tailored to patient preferences and
injection schedules. Offer excellent options in terms of flexibility and
do not require invasive procedures like pellets or daily application like
creams/gels.
- Topicals:
Testosterone
creams, gels, or lotions with varying concentrations and bases to
address individual skin sensitivities. These are good options for those
patients opposed to needles and injections.
- Pellets:
Customizable in size and testosterone content for sustained release.
Provide several months’ worth of hormone release without having to
readminister a weekly injection or apply a daily topical cream.
- Other
Forms: Unique options like oral tablets or nasal sprays, though these
are less common.
This flexibility makes compounded testosterone ideal for
patients with specific requirements or sensitivities as well as being often
times, more cost effective.
Uses and Benefits
Both commercial and compounded testosterone aim to alleviate
symptoms of low testosterone and improve quality of life. However, compounded
testosterone offers additional benefits:
- Personalized
Dosing: Allows precise adjustments based on individual responses and
blood test results. One can maximize their dose in the most minimal volume
as well as utilize the ester that agrees most with the patient’s specific
genetic preference to the medication.
- Alternative
Formulations: Addresses allergies or sensitivities to commercial
product ingredients. Some patients may experience side effects from some
formulas and a compounding pharmacy can make the necessary changes to
alleviate the symptoms.
- Enhanced
Compliance: Provides more convenient or comfortable options, such as
customized cream bases or tailored injection schedules to ensure there are
no lapses in dosing while following their doctors’ instructions and
protocol.
Cost and Insurance Coverage
Cost is a significant factor when choosing between
commercial and compounded testosterone. Commercial brands are often covered by
insurance, although out-of-pocket costs can vary depending on the product,
dosage, and insurance plan. Also, insurance companies may require a physician to
prescribe a certain form and dose for reimbursement. In other words, the
insurance company makes the patients protocol and if the doctor doesn’t follow
it, they don’t get paid, and the patient would be responsible for the costs if
they want to be treated. Patients looking to use insurance
for TRT need to call their insurance provider to see what the specific
requirements are for coverage. On the other hand, compounded testosterone is
rarely covered by insurance, leading to out-of-pocket costs, but they do
receive the protocol that will be best suited to their specific needs. Pricing
for compounded medications depends on the formulation, quantity, and
compounding pharmacy. Many clinics that specialize in hormone replacement
therapy offer all inclusive HRT programs which make the treatment more
affordable and convenient for patients seeking care from a qualified and
experienced provider. Low
T clinics offer several advantages in terms of convenience and expertise
over other providers who may not have the specific background when it comes to
this medical niche.
Considerations and Safety Concerns
While both options are effective, safety and quality are
paramount:
- Commercial
Brand: Backed by rigorous FDA
oversight, ensuring consistent quality and safety.
- Compounded
Testosterone: Requires careful selection of a reputable pharmacy to
ensure adherence to high-quality standards.
Both options carry potential side effects, including acne,
mood changes, increased red blood cell count, and cardiovascular risks. Regular
monitoring by a healthcare provider is crucial to mitigate these risks.
Making the Right Choice
Choosing between commercial and compounded testosterone
should be a collaborative decision between the patient and their healthcare
provider. Factors to consider include:
- Individual
Needs: Allergies,
sensitivities, lifestyle, and preferred method of administration.
- Medical
Necessity: Whether a compounded formulation is required to address
unique health conditions.
- Cost
and Insurance: Evaluating affordability and exploring insurance
coverage options.
- Quality
Assurance: Ensuring the compounding pharmacy has a strong reputation
for safety and consistency.
Commercial brand testosterone offers reliability and
FDA-approved safety, while compounded testosterone provides unmatched
customization and flexibility. Each option has its benefits and potential
drawbacks, and the decision should be guided by professional medical advice
tailored to the patient’s individual needs. By working closely with a qualified
healthcare provider, patients can make the best choice to achieve optimal
health and well-being. To learn more about testosterone therapy and how you can
get tested, diagnosed and treated, visit our website at www.NovaGenix.org or call/text us at
561-277-8260 today to schedule a free consultation.
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