FAQs

Frequently Asked Questions

Frequently Asked Questions

FAQs

General | Women | Men | Insurance | Compounding Pharmacy

General FAQ’s

Our concierge and traditional fee for service care offers an elevated, highly personalized approach that puts your needs front and center. Unlike standard HRT treatments, which are often rushed or one-size-fits-all, we provide dedicated one-on-one support. Together, we create a customized treatment plan, monitor your progress closely, and fine tune as needed. This approach ensures you receive expert, tailored menopause and andropause care that focuses on your unique health goals, extending beyond the limitations of traditional healthcare systems and the expertise of most conventionally trained providers.

All consultations are available to be conducted online through a secure, HIPAA-compliant video platform, allowing you to access expert care conveniently from the comfort and privacy of your home or office.  We do have clinic hours that vary weekly for patients who need to meet personally, although our experience has been most patients prefer virtual consultations.

Traditional HRT often uses synthetic hormones or those derived from animals, which may have a different molecular structure from human hormones.  BHRT uses plant-derived hormones that are modified to match human hormones identically, making them easier for the body to recognize and process.  We also offer BHRT with certified 100% organic oils –  Same hormones, naturally delivered. It’s that simple.

Women’s FAQ’s

Balanced hormones not only alleviate menopause and symptoms like hot flashes, brain fog, and mood swings but also play a vital role in preventing long-term health risks. Key hormones like estrogen, progesterone, and testosterone are essential for maintaining bone density, heart health, and cognitive function. Supporting hormone balance reduces the risk of conditions such as osteoporosis, cardiovascular disease, and dementia, promoting overall longevity and wellness beyond symptom management.

We take a highly personalized approach to hormone dosing. For menopausal women, we use a comprehensive 24-hour urine or saliva testing to evaluate hormone levels, ensuring optimal protection for the brain, heart, and bones. For perimenopausal women, where hormone levels naturally fluctuate, we focus on symptom tracking and adjust dosing carefully to match your unique needs.

Male patients benefit from a full battery of blood tests to make sure we are staying within a safe range of multiple indicators while addressing symptom concerns.  All our patients start with low doses, which we titrate gradually until your symptoms are fully addressed, ensuring safety and effectiveness throughout your treatment.

Menopause marks the phase when a woman has gone 12 months without a menstrual period, indicating the ovaries have largely stopped producing estrogen, progesterone, and testosterone. Perimenopause, which typically begins about 10 years prior, is the transitional stage where hormone levels fluctuate and gradually decline. This phase often brings symptoms like hot flashes, brain fog, mood swings, and more. With over 150 recognized symptoms linked to hormonal changes, tailored care is essential for navigating both stages.

Topical BHRT delivers hormones through the skin directly into the bloodstream, bypassing the liver and avoiding “first pass” metabolism, which improves absorption and reduces side effects. Using organic oil as the carrier ensures a clean, natural delivery method free from synthetic additives and solvents often found in creams or patches. This approach promotes gentle, effective absorption, optimizing results while minimizing risks to the endocrine system.  If our organic option isn’t your highest priority, conventional custom compounded BHRT approaches are also available to get you back to that balanced version of you.

Side effects are rare when hormone levels are properly balanced. If they do occur, they are typically a sign of dosage adjustments being needed. Through careful monitoring and personalized titration, I minimize side effects and optimize your results to ensure you feel your best.

Many women and men experience significant symptom relief within 6 to 8 weeks of starting our BHRT protocols. However, individual responses vary, and ongoing adjustments may be necessary to achieve the optimal results.

Absolutely. Testosterone is an important component of BHRT for women, supporting sexual health, muscle mass, energy levels, and bone density. We include it when indicated as part of your comprehensive, individualized hormone treatment plan.

Mens FAQ’s

Andropause, often referred to as male menopause, is a condition characterized by a gradual decline in testosterone levels and other hormonal changes in aging men. Unlike menopause in women, andropause doesn’t involve a complete cessation of reproductive function but rather a slow reduction in hormone production over time.

Key Features of Andropause:

  1. Decline in Testosterone Levels: Testosterone levels typically decrease by about 1% per year after age 30–40. This hormonal decline can lead to noticeable physical, emotional, and sexual changes.
  2. Common Symptoms:
    • Low energy levels and fatigue
    • Reduced libido and sexual dysfunction
    • Mood changes, including irritability, depression, or anxiety
    • Decreased muscle mass and strength
    • Increased body fat, especially around the abdomen
    • Cognitive changes, such as difficulty concentrating or memory issues
    • Reduced bone density, increasing the risk of fractures
  3. Causes:
    • Natural aging is the primary cause.
    • Lifestyle factors, such as poor diet, lack of exercise, stress, and alcohol use, can exacerbate symptoms.
    • Medical conditions like obesity, diabetes, or chronic illness may contribute to the decline in testosterone levels.
  4. Diagnosis: Andropause is diagnosed based on symptoms and confirmed through blood tests that show low testosterone levels.
  5. Treatment Options:
    • Lifestyle Changes: Regular exercise, a healthy diet, stress reduction, and quality sleep can alleviate many symptoms.
    • Testosterone Replacement Therapy (TRT): In men with clinically low testosterone, TRT can restore hormonal balance and improve symptoms.
    • Human Growth Hormone Therapy: Human Growth Hormone can be injected to address the same symptoms in younger men who are still concerned with maintaining their fertility.  HGH under proper supervision can restore hormonal balance until a patient is comfortable with the potential loss of fertility.

Hormone balance is crucial for men not just for alleviating symptoms but for supporting long-term health, vitality, and disease prevention. Here’s why maintaining optimal hormone levels goes far beyond symptom management:

  1. Disease Prevention
    • Cardiovascular Health: Hormones like testosterone and growth hormone support heart health by improving cholesterol levels, reducing visceral fat, and maintaining arterial elasticity. Low testosterone has been linked to an increased risk of heart disease.
    • Bone Density: Testosterone and other hormones play a key role in bone remodeling and density. Hormonal imbalances can increase the risk of osteoporosis and fractures.
    • Metabolic Health: Proper hormone levels help regulate insulin sensitivity and glucose metabolism, reducing the risk of type 2 diabetes.
  2. Cognitive and Emotional Well-Being
    • Brain Health: Hormones influence brain function, memory, and mental clarity. Imbalances, especially low testosterone or thyroid hormones, can lead to brain fog, depression, and cognitive decline.
    • Mood Stability: Balanced hormones regulate neurotransmitters like serotonin and dopamine, reducing anxiety, irritability, and emotional instability.
  3. Physical Function and Longevity
    • Muscle Maintenance: Testosterone supports protein synthesis and muscle repair, essential for maintaining strength and mobility with age. Muscle loss (sarcopenia) contributes to frailty and a decline in quality of life.
    • Energy Production: Hormones like thyroid hormone, testosterone, and growth hormone regulate energy metabolism at the cellular level, ensuring optimal performance and stamina.
  4. Sexual and Reproductive Health
    • Libido and Fertility: Testosterone and other hormones are essential for a healthy sex drive and sperm production. Imbalances can lead to erectile dysfunction or infertility.
    • Prostate Health: Balanced hormone levels contribute to healthy prostate function and may help reduce the risk of benign prostatic hyperplasia (BPH) and prostate cancer.
  5. Immune System Support
    Hormones like testosterone and DHEA have immune-modulating effects. Imbalances can weaken immune responses, increasing susceptibility to infections and inflammatory conditions.
  6. Quality of Life and Aging
    Balanced hormones allow men to age more gracefully by preserving physical, mental, and emotional health. Proper balance reduces the risk of chronic diseases, supports recovery from illness, and promotes a higher overall quality of life.

The Bigger Picture

Hormone balance is about optimizing the body’s systems to work in harmony, supporting overall health and longevity. While symptom relief is important, the broader goal of hormone balance is to prevent disease, improve resilience, and ensure that men can lead active, fulfilling lives as they age.

For men approaching andropause or experiencing hormonal imbalances, regular testing and working with one of our knowledgeable providers can ensure that treatment not only alleviates symptoms but also promotes long-term wellness.

Bioidentical Hormone Replacement Therapy (BHRT) for men, while effective for restoring hormonal balance, carries some risks that should be carefully considered and managed under medical supervision. Here’s an overview of the potential risks and strategies for prevention or mitigation:

Risks of BHRT for Men:

  1. Cardiovascular Issues
    • Risk: Elevated testosterone levels can lead to increased red blood cell production (polycythemia), raising the risk of blood clots, stroke, or heart attack.
    • Prevention:
      • Regular blood work to monitor hematocrit, hemoglobin, and red blood cell counts.
      • Therapeutic phlebotomy (if necessary) to manage high hematocrit levels.
      •  Careful dosing to avoid supraphysiological testosterone levels.
  2. Prostate Health Concerns
    • Risk: Historically, there was concern that testosterone therapy could fuel prostate cancer growth. While research shows this is not necessarily true, men with existing prostate cancer or at high risk must proceed cautiously.
    • Prevention:
      • Baseline and ongoing PSA (prostate-specific antigen) testing.
      • Digital rectal exams and monitoring for prostate health.
      • Avoid BHRT if there’s an active or untreated prostate condition.
  3. Hormonal Imbalance and Overdosing
    • Risk: Excess testosterone can lead to the conversion of testosterone to estrogen (via aromatization), causing symptoms like gynecomastia (male breast enlargement) or fluid retention.
    • Prevention:
      • Monitor estradiol levels regularly.
      • Use aromatase inhibitors, if needed, under medical guidance.
      • Adjust dosage based on lab results and symptoms.
  4. Infertility
    • Risk: Exogenous testosterone can suppress natural testosterone production and decrease sperm production, potentially leading to infertility.
    • Prevention:
      • Include human chorionic gonadotropin (hCG) or clomiphene citrate in the protocol to preserve fertility.
      • Discuss fertility plans before starting BHRT.
  5. Sleep Apnea
    • Risk: Testosterone therapy may worsen or unmask sleep apnea in some men.
    • Prevention:
      • Evaluate for sleep apnea before starting BHRT, especially in men with risk factors like obesity or snoring.
      • Treat existing sleep apnea with CPAP or other interventions.
  6. Mood Changes and Aggression
    • Risk: Excess testosterone may lead to irritability, mood swings, or aggressive behavior in some men.
    • Prevention:
      • Maintain testosterone levels within the optimal physiological range.
      • Monitor emotional well-being and communicate concerns with your doctor.
  7. Fluid Retention and Edema
    • Risk: Testosterone can cause water retention, leading to swelling in the legs or feet.
    • Prevention:
      • Regular monitoring of weight and blood pressure.
      • Adjust testosterone dosage if fluid retention occurs.
  8. Gynecomastia
    • Risk: Increased estrogen levels from testosterone aromatization can lead to the development of breast tissue in men.
    • Prevention:
      • Monitor estradiol levels regularly.
      • Consider aromatase inhibitors or dosage adjustments if necessary.
  9. Skin Issues
    • Risk: Acne or oily skin may develop, especially with testosterone use.
    • Prevention:
      • Maintain hormone levels within the normal range.
      • Use topical treatments or adjust testosterone form.
  10. Long-Term Safety Concerns
    • Risk: The long-term effects of BHRT, particularly testosterone replacement therapy, are still being studied.
    • Prevention:
      • Stay informed about emerging research.
      • Work with an experienced provider in BHRT – at Balanced BHRT, we are constantly researching and evolving our therapies to keep up with the latest advances in efficacy and safety in hormonal health.

Insurance FAQ’s

Balanced BHRT does not accept insurance; however, FSA and HSA funds are welcome for eligible services. Our experience has been, many of the tests we order such as blood work, mammograms, dexa scans, and ultrasounds may still be covered by your insurance.

Most insurance plans and Medicare do not typically cover bioidentical hormone replacement therapy (BHRT) because of several factors:

  1. Lack of FDA Approval for Custom Compounded BHRT
    • Many bioidentical hormones are custom-compounded by pharmacies, tailored to the individual patient. These compounded hormones are not regulated or approved by the FDA, which raises concerns about safety, efficacy, and consistency in dosing.
    • Insurance companies and Medicare generally limit coverage to treatments that are FDA-approved and meet established standards for manufacturing and quality.
  2. Availability of FDA-Approved Alternatives
    • There are FDA-approved hormone therapies that may be covered by insurance (e.g., certain forms of estradiol and progesterone). These are often considered sufficient for most patients, even though they may not be bioidentical or customized.  Few PCP’s are trained in their use and most practitioners who specialize in hormone replacement therapy utilize custom compounded bioidenticals.
    • Insurers often view compounded BHRT as unnecessary when approved alternatives are available.
  3. Limited Large-Scale Clinical Evidence
    • While many patients report benefits from BHRT, large-scale, long-term studies supporting the safety and efficacy of compounded bioidentical hormones are lacking.  Large scale trials are the realm of large pharmaceutical companies which are unable to patent BHRT compounds which reduces the incentives for such studies.
    • Insurance companies prioritize treatments backed by extensive research, and the lack of such evidence makes BHRT less likely to be covered.
  4. Perception of BHRT as a “Wellness” or Elective Treatment
    • BHRT is sometimes categorized as a lifestyle or elective therapy rather than a medically necessary treatment.
    • Insurers often exclude therapies they consider non-essential or outside the scope of conventional medical care.
  5. Higher Costs of Custom Compounding
    • Custom-compounded hormones can be significantly more expensive than standard hormone therapies. Insurance companies may not want to bear the cost of these tailored treatments, especially without clear evidence of added benefits. 

Options for Patients Unfortunately, wellness and individualized medicine is not the focus of health care in the US.  However, patients do have the option to benefit from the use of qualifying dollars within Health Savings Accounts (HSAs) or Flexible Spending Accounts (FSAs). These accounts may allow you to use pre-tax dollars for BHRT expenses.

Compounding Pharmacy FAQ’s

Compounding pharmacies that dispense bioidentical hormone replacement therapy (BHRT) operate under specific regulatory frameworks and are subject to oversight from various authorities to ensure patient safety, product quality, and consistency. Here’s a deeper look into the regulations governing these pharmacies:

  1. Governing Authorities for Compounding Pharmacies
    Compounding pharmacies in the United States are regulated primarily by the following authorities:
    • State Boards of Pharmacy: Each state’s board of pharmacy sets licensing requirements, conducts inspections, and enforces state-specific regulations for pharmacies. These boards play a critical role in ensuring compliance with compounding standards, including those for bioidentical hormones.
    • Food and Drug Administration (FDA): Although the FDA does not approve compounded medications, it does oversee compounding practices. The FDA regulates the bulk drug substances that compounding pharmacies use and enforces requirements under the Drug Quality and Security Act (DQSA), enacted in 2013. This law distinguishes between:
    • 503A Compounding Pharmacies: Traditional compounding pharmacies that make drugs based on individual prescriptions. They are exempt from certain FDA requirements but must follow state pharmacy board regulations.
    •  503B Outsourcing Facilities: Larger compounding facilities that produce medications in bulk without patient-specific prescriptions. These facilities are subject to stricter FDA oversight, including adhering to Current Good Manufacturing Practices (CGMPs).
    •  U.S. Pharmacopeia (USP): The USP sets quality and safety standards for compounding practices through guidelines such as USP <795> (non-sterile compounding) and USP <797> (sterile compounding). These guidelines establish requirements for preparation, handling, and storage to ensure consistency and safety in compounded medications.
  2. Safety Standards for Compounded Bioidentical Hormones
    Compounding pharmacies dispensing bioidentical hormones must follow several safety protocols:
    • Quality of Ingredients: Pharmacies must source their ingredients from FDA-approved suppliers and ensure each ingredient’s purity, strength, and stability. Any raw materials used must meet USP standards for quality.
    • Sterility and Contamination Control: Although bioidentical hormones are often non-sterile (like creams or capsules), pharmacies still adhere to rigorous procedures to prevent contamination. This includes maintaining clean rooms and sterile workspaces to protect from contaminants.
    • Labeling and Patient Instructions: Compounded medications are labeled with the hormone dosage, instructions for use, storage conditions, and expiration date. Patients receive clear instructions on how to use the medications safely and effectively.
    • Batch Testing: Some compounding pharmacies conduct potency and sterility testing on compounded products, especially if they are 503B outsourcing facilities. Testing can include verifying hormone concentrations and screening for contaminants.
  3. Laboratory and Quality Control Standards
    Quality control is crucial for compounding bioidentical hormones due to the custom dosages and forms required. Standards include:
    • Facility Requirements: Compounding pharmacies must maintain facilities that meet USP standards. This includes separate areas for compounding, proper ventilation, and cleanroom standards if needed.
    • Staff Training and Certification: Pharmacists and technicians in compounding pharmacies undergo specialized training to understand dosage accuracy, hormone handling, and patient safety.
    • Equipment Calibration and Maintenance: Compounding pharmacies must use precise measuring and mixing equipment that is regularly calibrated to ensure dosing accuracy.
    • Documentation and Traceability: Pharmacies must maintain meticulous records of each compounded medication’s formula, preparation steps, and quality checks. This documentation ensures traceability in case of any issues or recalls.
    • Stability Testing and Expiration Dates: Pharmacies need to conduct stability testing to determine the shelf life of compounded medications. Expiration dates ensure patients are using the products within a safe period.
  4. Oversight and Enforcement
    Regulatory authorities conduct periodic inspections to ensure that compounding pharmacies comply with these standards. The FDA may inspect 503B facilities and can take action if a pharmacy fails to meet CGMPs or other safety standards. State boards of pharmacy also perform inspections, which can lead to penalties, license suspension, or closure for pharmacies that do not meet regulatory requirements.
  5. Limitations and Controversies
    Although compounding pharmacies follow strict protocols, compounded bioidentical hormones are not “FDA-approved”, which even when considering everything outlined above still raises some controversy. Critics of compounding pharmacies tout concerns about inconsistencies in potency and purity between batches of medication. Advocates, however, argue that compounded BHRT provides tailored solutions for patients who cannot or prefer not to use commercially available options.  The opponents of the customized formulations of these medications call for greater oversight and more standardization despite everything that is already being done above.  Effectively these high standards are why custom formulations are more expensive than mass produced “one size fits most” FDA approved alternatives.

To understand the differences you must consider the definitions of each class of therapy and the ability of each to be customized to the needs of an individual patient, the regulatory and quality control differences between each class, the sources of each class of hormone, the availability and costs variables, the clinical and research evidence that underpins the utilization of each class of hormone, and finally the use cases for each.  Careful consideration of all these parameters must be evaluated to decide which path is best for each individual considering the replenishment of their hormone levels.

  1. Definition and Customization
    • Compounded BHRT:
      • Custom-made formulations prepared by compounding pharmacies.
      • Tailored to individual patients based on hormone testing, symptoms, or preferences.
      • Can include a variety of delivery methods (creams, gels, troches, capsules, etc.) and customized dosages.
    •  FDA-Approved BHRT:
      • Standardized formulations approved by the FDA for specific uses and dosages.
      • Typically, available in limited forms like pills, patches, gels, and injections.
      • Includes products like estradiol (e.g., Estrace, Climara) or micronized progesterone (e.g., Prometrium), which are bioidentical but not compounded.
    • FDA-Approved HRT
      • Hormones Used: Includes synthetic hormones or hormones derived from animal sources (e.g., conjugated equine estrogens like Premarin).
      • Structure: These hormones may not be identical in structure to the hormones naturally produced by the human body.
        •  Examples: Premarin, Provera, Prempro.
  2. Regulation and Quality Control
    • Compounded BHRT:
      • Not FDA-approved, meaning the specific formulations and dosages are not tested for safety, efficacy, or consistency.
      • Quality can vary depending on the compounding pharmacy’s standards and expertise.
      • Often prescribed when patients require specialized dosages or combinations not available in FDA-approved products.
    • FDA-Approved BHRT:
      • Rigorously tested in clinical trials for safety, efficacy, and consistent dosing.
      • Manufactured under strict FDA-regulated conditions.
      • May have better standardization and reliability compared to compounded formulations.
    • FDA-Approved HRT
      • Approval: These therapies have been rigorously tested and approved by the FDA for safety, efficacy, and consistent dosing.
  3. Hormone Sources
    • Compounded BHRT:
      • Typically derived from natural plant sources like yams or soy and chemically identical to the hormones your body produces.
      • Marketed as “natural” or closer to the body’s own hormones, although the term “bioidentical” refers to the molecular structure, not the source.
    • FDA-Approved BHRT:
      • Also derived from plant sources and chemically identical to the hormones your body produces.
      • Uses similar bioidentical hormones but in pre-set dosages and delivery methods.
    • FDA-Approved HRT
      • Hormones Used: Includes synthetic hormones or hormones derived from animal sources (e.g., conjugated equine estrogens like Premarin).
  4. Availability and Cost
    • Compounded BHRT:
      • Requires a prescription and is made at a compounding pharmacy.
      • Costs vary and are usually not covered by insurance or Medicare.
      • Often perceived as more expensive due to its customized nature.
    • FDA-Approved BHRT:
      • Widely available at retail pharmacies.
      • More likely to be covered by insurance or Medicare, making it more affordable for many patients.
    • FDA-Approved HRT
      • Widely available at retail pharmacies.
      • More likely to be covered by insurance or Medicare, making it more affordable for many patients.
  5. Evidence and Clinical Research
    • Compounded BHRT:
      • Limited large-scale, peer-reviewed research to support safety and efficacy.
      • Advocates claim benefits based on individual experiences and small studies, but the lack of robust data raises concerns for some clinicians.
    •  FDA-Approved BHRT:
      • Backed by extensive clinical trials and long-term research.
      • Side effects, benefits, and risks (such as blood clots, stroke, or breast cancer) are better understood.
    • FDA-Approved HRT:
      • Backed by extensive clinical trials and long-term research.
      • Side effects, benefits, and risks (such as blood clots, stroke, or breast cancer) are better understood.
  6. Use Cases
    • Compounded BHRT:
      • Often prescribed when patients need tailored solutions (e.g., unusual hormone levels, allergies to ingredients in standard products, or preference for non-standard delivery methods).
      • Examples: A mix of estriol and estradiol (not available in FDA-approved forms) or custom low-dose formulations.
    • FDA-Approved BHRT:
      • Used for most patients with common hormone imbalances or menopause symptoms.
      • Standardized products are sufficient for many cases without the need for customization.
    • FDA-Approved HRT:
      • Used for most patients with common hormone imbalances or menopause symptoms.
      •  Standardized products are sufficient for many cases without the need for customization.

Which Option is Better?

The choice depends on your individual needs and circumstances:

  • If you require specific combinations (such as the use of testosterone for women) or dosages unavailable in FDA-approved products, compounded BHRT might be better.  Balanced BHRT specializes in this individualized approach that allows infinite refinement of your therapy – this is our expertise.

  • If you want a treatment with insurance coverage, and standardized dosing, large batch level quality controls, FDA-approved BHRT or FDA-approved HRT could be a more cost-effective option.  There are conventionally trained providers who prescribe these regimens.  Hopefully you PCP, OB/Gyn, or urologist is able to assist you in this path. While we firmly believe our model of care is optimal, we certainly advocate for any patient experiencing the symptoms of peri menopause, menopause, or andropause to find a version of HRT that works for them.