Monday, March 10, 2025

TRT and Blood Pressure: Does Testosterone Raise or Lower Hypertension Risk?

The Effects of Testosterone on Blood Pressure in Hypogonadal Men


The Complex Relationship Between Testosterone and Blood Pressure in Hypogonadal Men

As more and more men are looking to turn back the clock by starting hormone replacement therapy regimens, there are some concerns regarding the safety and potential for negative side effects from taking medications to influence hormones, specifically testosterone and estrogen in hypogonadal men. Testosterone replacement therapy (TRT) has been widely studied for its benefits in men with low T, or hypogonadism which is a condition characterized by low testosterone levels. The range may vary based on age and other factors; however the typical standard has been between 250-1000 ng/dl. While TRT has been shown to improve several different aspects of health, including muscle mass, strength, libido, bone density, and mood, its effects on blood pressure (BP) still remains a subject of debate amongst those in the medical profession. Patients often ask us if “taking testosterone will increase their blood pressure?” Some studies have suggested that TRT may contribute to hypertension, while others indicate a potential for BP reduction. With conflicting evidence, we have to ask what’s the evidence and why is there a discrepancy between conclusions?  In the following blog post, we’ll investigate the findings from multiple studies to provide a comprehensive overview of the relationship between testosterone and blood pressure in hypogonadal men and how TRT can either contribute to the increase or decrease in BP for patients.



Testosterone and Blood Pressure: Conflicting Perspectives

The effects of TRT on BP have been examined in multiple studies from various researches with differing conclusions. Some reports, such as those from Geoffrey Hackett et al., suggest to us that testosterone undecanoate (TU) therapy may be associated with significant reductions in both systolic and diastolic blood pressure as well as pulse pressure in hypogonadal men, regardless of whether or not they are on any antihypertensive therapy.  Antihypertensive therapy can include medications like diuretics, (ACE) Inhibitors, Angiotensin II Receptor Blockers or beta blockers. In their study, the findings indicate that men who were never on antihypertensive medications experienced BP reductions of -12.5 mmHg (systolic), -8.0 mmHg (diastolic), and -6.0 mmHg (pulse pressure) at final assessment. In contrast, their study showed that the men who did not receive TU showed increases in blood pressure over time.

However, a randomized controlled trial performed by Olesen et al. presented a completely different perspective from Hackett. This study found that men with opioid-induced androgen deficiency who received TRT experienced an average systolic BP increase of 6.2 mmHg, compared to a 7.0 mmHg decrease in the placebo group. Notably, men with higher hematocrit levels and elevated body mass index (BMI) appeared more susceptible to BP increases. These findings suggest that hematocrit levels may modulate BP responses to TRT but it also needs to be stated that these patients all had low T that was a result of taking opioids and not reflective of most typical cases of androgen deficiency.  It’s also important to ask what were the patients testosterone levels PRIO to their opioid dependency? Did they take a Low T test prior or is the reading of low testosterone post dependency the first time their hormone levels were checked? We do know that that heroin and opioids will lower testosterone levels however having a baseline reading that can be validated both before and after is important for researchers to determine valid conclusions and a credible hypothesis.



Hematocrit and Its Role in BP Regulation

One of the primary concerns with TRT is its potential to elevate hematocrit, which can increase blood viscosity and raise BP.  Testosterone therapy has been known to cause secondary erythrocytosis which can cause symptoms of hyperviscosity, such as headaches, low energy or fatigue, blurry vision and even paresthesias. If a patient on TRT has hematocrit levels of over 54, they should consider taking measures such as reducing their dosage of testosterone, staying well hydrated and in some cases many doctors will even recommend therapeutic phlebotomy.  Elevated hematocrit has been identified as an independent risk factor for stroke, particularly when combined with high blood pressure. This is the mechanism that explains why some men on TRT can experience increased BP, as seen in Olesen et al.'s study. However, the findings from Hackett et al. indicate that hematocrit was not significantly associated with BP changes in their cohort, suggesting that the relationship may vary based on individual physiological responses. Factors like genetics, age and overall health and fitness levels as well as diet and other lifestyle factors could all potentially influence BP responses to men on TRT and need to be studied further.



Mechanisms Behind Testosterone's BP Effects

Its hard for most people to process why you can have multiple studies with differing results. The mixed findings regarding TRT and BP can potentially be attributed to several different physiological mechanisms, such as:

  1. Endothelial Function Improvement: Testosterone has been shown to enhance endothelial function by reducing oxidative stress and increasing nitric oxide production, which promotes vasodilation and lowers BP. The endothelium is the thin layer of cells that line the inside of blood vessels and are key in regulating vascular health. They help to maintain blood flow, vascular tone, and overall cardiovascular function.
  2. Reduction in Insulin Resistance: Some studies indicate that TRT decreases insulin resistance, a factor that is often linked to hypertension. Insulin resistance is a condition where the body's cells become less responsive to insulin, the hormone that helps to regulate blood sugar (glucose) levels.
  3. Aldosterone Suppression: Testosterone may lower aldosterone levels, by reducing sodium retention in the body and thus lowering blood pressure. Aldosterone is a hormone made in the adrenal glands and helps with regulating blood pressure, sodium (salt), and potassium levels in the body. It is part of the renin-angiotensin-aldosterone system (RAAS) and works by increasing sodium and water retention (raising blood pressure), Promoting potassium excretion through urine and Autonomic Nervous System Regulation: TRT has been associated with improved autonomic function, which could contribute to better BP control.


The Impact of TRT on Enhancing the Effects of Antihypertensive Therapy

TRT’s interaction with antihypertensive medications is another important consideration for men with BP concerns who may also be on hormone therapy. The long-term study by Hackett et al. found that for men who are receiving both TRT and antihypertensive medications, BP reductions were more pronounced than for those in the placebo group. Additionally, they reported that 16.4% of men on antihypertensive therapy at baseline discontinued their medication by the study's end, which suggested an additive or synergistic effect of TRT on BP regulation based on their conclusions.

Blood Pressure Monitoring and Safety Considerations

Its hard for patients to determine the potential effect that TRT may have on their BP prior to starting treatment. So, given that the potential for TRT to both raise and lower BP depending on individual factors, monitoring by a licensed and experienced healthcare provider is essential. A solitary BP reading is often unreliable due to natural fluctuations throughout the day. To get a true idea of one’s blood pressure, there should be multiple reading throughout the day over a course of several days.  For example, the British Hypertension Society recommends a BP target of <140/90 mmHg, with ambulatory blood pressure monitoring (ABPM) being the “gold standard “for diagnosing hypertension. TRT patients should undergo regular BP assessments, including hematocrit monitoring via blood tests, to mitigate risks associated with elevated blood viscosity.



How To Determine if TRT Will Impact Your Blood Pressure

Unfortunately, as we have seen, the effects of testosterone on blood pressure in hypogonadal men is both complex and is often influenced by multiple different factors, which will include things like baseline BP, hematocrit levels, BMI, and whether a patient is concurrently on antihypertensive therapy. Men how have taken tests for low T and have been diagnosed with hypogonadism need to assess their BP as part of determine the benefits of TRT.  While some studies demonstrate a clear BP-lowering effect of TRT, particularly in men with higher baseline BP, other studies highlight the potential risk of BP elevation when taking testosterone, particularly for those patients who already have increased hematocrit levels. That’s why we recommend individualized monitoring and patient-specific management strategies for patients on TRT. These are both crucial steps for optimizing the benefits of TRT while minimizing cardiovascular risks for patients. By understanding your risk factors an experienced healthcare provider may also be able to use that information to determine the best protocol to help ensure you get the most out of your hormone therapy while minimizing risks.

Learn more about us at NovaGenix here and see how TRT can impact your life.



Monday, February 24, 2025

Wegovy & Ozempic Shortage Over: Supply Stabilizes and FDA Moves to Limit Compounded Alternatives.

 

GLP-1 Availability Shifts: FDA Actions Impact Compounded Wegovy and Ozempic After Removal From Drug Shortage List



February 21, 2025 - The landscape of GLP-1 medication availability is undergoing significant changes, with the U.S. Food and Drug Administration (FDA) announcing the resolution of shortages for key drugs like semaglutide (Wegovy and Ozempic) and tirzepatide (Zepbound and Mounjaro). These decisions have major implications for compounding pharmacies and patient access to these popular weight-loss and diabetes medications. Patients who rely on affordable medication from reputable compounding pharmacies may now be required to purchase the brand named GLP-1 medications at a considerably higher cost which may make them unaffordable to many of the same people who rely on them 

Semaglutide Shortage Resolved, Compounding Restrictions Imminent:

The FDA has officially determined that the shortage of semaglutide injection products, including Wegovy and Ozempic, is resolved. This decision follows confirmation from Novo Nordisk, the manufacturer, that their production capacity can meet current and projected national demand. While localized supply disruptions may occur as products move through the supply chain, the overall national shortage is considered over. Compounding pharmacies and organizations are determined to fight this ruling in the courts as the belief is that between diabetic patients and those who are reliant on them for weight loss, that the large manufacturers of the drugs will not be able to keep up with the demand despite their reassurances 

This resolution triggers restrictions on compounding pharmacies that have been producing versions of these drugs during the shortage. To ensure a smooth transition for patients, the FDA has provided a grace period:

  • 503A Pharmacies (State-Licensed): Compounding, distribution, and dispensing of semaglutide injection products that are essentially copies of FDA-approved products is allowed for 60 calendar days from February 21, 2025, until April 22, 2025.
  • 503B Outsourcing Facilities: Compounding, distribution, and dispensing of semaglutide injection products is allowed for 90 calendar days from February 21, 2025, until May 22, 2025.


Tirzepatide Shortage Also Addressed:

Similarly, the FDA has also declared the tirzepatide shortage resolved, following a re-evaluation of its previous determinations. This decision, mirroring the semaglutide action, activates similar grace periods for compounding pharmacies. Much like Wegovy and Ozempic, commercial grade Mounjaro (Tirzepatide) has been a huge breakthrough for weight loss and patients have had tremendous results while taking the subcutaneous injections. Unfortunately the grace period is about to end and many compounding pharmacies will no longer me manufacteuring these drugs which will spike the demand and costs for certain.

  • 503A Pharmacies: Compounding, distributing or dispensing tirzepatide injections within 60 calendar days from December 19th 2024, until February 18, 2025.
  • 503B Outsourcing Facilities: compounding, distributing or dispensing tirzepatide injections within 90 calendar days from December 19th 2024, until March 19, 2025.

It is important to note, that despite these grace periods, the FDA retains the authority to take action against compounders for violations of other statutory or regulatory requirements, particularly regarding substandard quality or unsafe products.

Impact on Compounding Pharmacies and Market Dynamics:

The FDA's decisions have significant market repercussions. Companies like Hims & Hers Health, which have heavily promoted compounded versions of GLP-1 medications, have seen substantial stock declines. The ability to produce and sell these compounded versions, which are often cheaper than brand-name drugs, is now significantly curtailed.

The Alliance for Pharmacy Compounding has raised concerns about the transition for patients currently relying on compounded medications, emphasizing the need for a smooth shift to FDA-approved alternatives.



Ongoing Monitoring of GLP-1 Availability:

The FDA continues to actively monitor the availability of other GLP-1 medications, including dulaglutide and liraglutide, which remain in shortage. The agency stresses that while manufacturers may report "available" status for certain products, this does not constitute an official FDA determination that the shortage is resolved.

Key Considerations:

  • FDA Enforcement: The FDA emphasizes the legal restrictions on compounding copies of FDA-approved drugs, particularly when shortages are resolved.
  • Patient Transition: Patients currently using compounded GLP-1 medications should consult with their healthcare providers to discuss transitioning to FDA-approved alternatives.
  • Supply Chain Stability: While national shortages are resolved, localized supply disruptions may still occur.
  • Safety and Quality: FDA-approved drugs undergo rigorous review for safety, effectiveness, and quality, whereas compounded drugs do not receive the same level of oversight but still receive quality control measures as do the pharmacies that manufacture them.

Where to Find Updates:

For the most current information on GLP-1 medication availability and drug shortages, please refer to the FDA’s Drug Shortages Database.

Thursday, February 20, 2025

Estrogen Levels in Women: Understanding Its Role in Women's Health

Estrogen Levels in Women: A Key to Understanding Female Health

How Estrogen Affects Women's Health: Signs, Symptoms, and Solutions

Many women come to us with generalized symptoms of perimenopause or menopause and have questions regarding their blood work. Often, we hear questions like “What are my estrogen levels?” and “What should my estrogen levels be at for my age?” It’s important to address what estrogen is and what role it plays in women’s health.  Estrogen is a group of steroid hormones that play a crucial role in the female reproductive system and their overall health. It’s one of the major hormones that’s responsible for the development of female sexual characteristics, regulation of the menstrual cycle, and helps influence various other bodily functions. Estrogen levels naturally fluctuate throughout a woman's life, and understanding these changes is important when it comes to maintaining well-being.  


What is Estrogen?

There are three main types of estrogen in women which are primarily produced in females by the ovaries, with smaller amounts coming from the adrenal glands and fat tissue.

·         Estradiol (E2): The most potent and abundant form of estrogen, primarily produced by the ovaries playing a key role in reproductive health and is measured in blood tests to assess estrogen levels.   Normal estradiol (E2) levels in women vary depending on their age and menopausal status:   Premenopausal women: 30 to 400 pg/mL and Postmenopausal women: 0 to 30 pg/mL

Estrone (E1): A weaker form of estrogen present in lower levels than estradiol. It becomes the dominant estrogen after menopause.  Individual levels will vary from one womean to the next but here is are general ranges. Premenopausal women: 27 to 231 pg/mL  Postmenopausal women: 0 to 125 pg/mL


Estriol (E3): The weakest form of estrogen, mainly produced during pregnancy. Its role in non-pregnant women is not fully understood.   Estriol levels are typically not measured in non-pregnant women.  



What Does Estrogen Do?

The million-dollar question is “What does estrogen do?”  Estrogen exerts its effects in women by binding itself to specific receptors in various tissues throughout the woman’s body. These receptors are found in tissue and organs such as:  

  • Reproductive organs: Uterus, vagina, breasts  
  • Brain: Affects mood, cognition, and sleep  
  • Bones: Maintains bone density and strength  
  • Heart: Influences cholesterol levels and blood vessel function  
  • Skin: Contributes to skin elasticity and hydration  

Estrogen Levels Throughout Life

What do normal estrogen levels look like throughout a woman’s life? As it turns out, Estrogen levels will naturally fluctuate throughout a woman's life, influenced by puberty, menstrual cycles, pregnancy, and menopause.  This can be confusing at times and even cause unwanted symptoms such as mood change, hot flashes and night sweats, menstrual cycle irregularity to name a few but don’t worry. This is completely normal and can be addressed by your healthcare provider if needed.

  • Puberty: Estrogen levels rise, triggering the development of female sexual characteristics, including breasts, menstruation, and changes in body shape.  
  • Menstrual cycle: Estrogen levels fluctuate throughout the menstrual cycle, peaking just before ovulation and then declining.  
  • Pregnancy: Estrogen levels steadily increase during pregnancy, supporting the growth and development of the fetus and see a boost of E3.  
  • Menopause: Estrogen levels significantly decline as the ovaries stop producing eggs, leading to various physical and emotional changes and E1 becomes the dominant form of estrogen.  


Normal Estrogen Levels

Normal estrogen levels vary depending on age and menopausal status. Here's a general guideline for estradiol (E2) levels:

Premenopausal women: 30 to 400 pg/mL  

Postmenopausal women: 0 to 30 pg/mL  

It's important to note that these are just general ranges, and individual levels may vary.  Also keep in mind that these number will fluctuate and every patient is unique so if you suspect there may be an issue with your hormones, speak to your doctor about your concerns.  A healthcare provider can interpret estrogen levels in the context of a woman's overall health and medical history.

Effects of Low Estrogen

Low estrogen levels can lead to various symptoms, including:

  • Menstrual irregularities: Changes in cycle length, flow, or missed periods  
  • Hot flashes: Sudden feelings of warmth, sweating, and flushing  
  • Vaginal dryness: Discomfort during intercourse  
  • Sleep disturbances: Difficulty falling asleep or staying asleep  
  • Mood changes: Irritability, anxiety, or depression  
  • Decreased libido: Reduced sexual desire  in women
  • Bone loss: Increased risk of osteoporosis
  • Cognitive changes: Difficulty concentrating or remembering things


Estrogen Replacement Therapy (ERT)

Hormone Replacement Therapy for women is a very common treatment option for women experiencing the unwanted signs and symptoms of perimenopause of menopause. It often includes estrogen, testosterone and progesterone. Estrogen replacement therapy (ERT) in particular involves taking medication to increase estrogen levels back to an optimal level for the patient. It is primarily used to manage menopausal symptoms and prevent bone loss. ERT can be delivered in various forms, including:  

  • Oral tablets: The most common form of ERT. These are generally best taken after a meal to reduce the risk of stomach upset and improve absorption. Some women find it helpful to take them in the morning to maintain consistent hormone levels throughout the day.
  • Transdermal patches: Applied to the skin, delivering estrogen directly into the bloodstream. These are typically replaced every few days. The time of day for application is less critical, but it's important to choose a consistent time and location for each application.  
  • Topical gels or creams: Applied to the vagina or vulva. The time of day for application may depend on the specific product and individual needs.
  • Vaginal rings: Inserted into the vagina, releasing estrogen over time. They provide a continuous release of hormones.


Benefits of ERT for Women

ERT can provide several benefits, including:

  • Relief from menopausal symptoms: Reduces hot flashes, vaginal dryness, sleep disturbances, and mood changes  
  • Prevention of bone loss: Helps maintain bone density and reduce the risk of osteoporosis  
  • Improved quality of life: Enhances overall well-being and reduces the impact of menopausal symptoms  

Risks of ERT

Like all medications and medical treatments ERT also carries potential risks, including:

  • Increased risk of certain cancers: ERT may increase the risk of breast cancer and endometrial cancer so it’s important to get screened. The U.S. Preventive Services Task Force (USPSTF) recommends that women aged 40 to 74 years with average risk get screened every 2 years, however, the American Cancer Society (ACS), recommend annual mammograms starting at age 45, or even 40, depending on individual risk factors and preferences.   Higher risk patients with a family history of breast cancer should get tested more frequently.
  • Increased risk of blood clots: May increase the risk of deep vein thrombosis and pulmonary embolism  
  • Possible Increased risk of stroke and heart attack: ERT May increase the risk of cardiovascular events, especially in women with existing risk factors. Studies on the relationship between ERT and CVD have yielded mixed results. Some studies have shown an increased risk of heart attack, stroke, and blood clots in women taking ERT, while others have not found a significant association. Its important to discuss whether you’re in a high risk category for your age, overall health, family history and time since the onset of menopause to determine if there is an increased risk.


Who Should Consider ERT?

ERT is not suitable for all women. It is important to discuss the benefits and risks with a licensed and experienced healthcare provider to determine if it is appropriate for you. There are several factors to consider including:

  • Severity of menopausal symptoms: ERT may be more beneficial for women with severe symptoms that significantly impact their quality of life. Oten mild symptoms subside fairly quickly for many women.
  • Risk factors for certain cancers: Women with a personal or family history of breast cancer or endometrial cancer may have an increased risk with ERT and should weigh the risk/reward of HRT.
  • Risk factors for cardiovascular disease: Women with existing heart disease or risk factors for cardiovascular disease may have an increased risk with ERT and should look for other ways to alleviate symptoms first.


Alternatives to ERT

There are alternative treatments for managing menopausal symptoms and preventing bone loss for women, including:

  • Lifestyle changes: Regular exercise, a healthy diet, and stress management can help alleviate menopausal symptoms. Strength training in particular is beneficial. Strength training can stimulate the production and balance of various hormones, including growth hormone, testosterone, and estrogen. This can help alleviate symptoms associated with hormone imbalances, such as mood swings, fatigue, and weight gain.  
  • Non-hormonal medications: Certain medications can help reduce hot flashes and improve sleep.   These medications work through different mechanisms than hormone replacement therapy (HRT) and may be suitable for women who cannot or choose not to take HRT.  

Here are some common non-hormonal medications used for hot flashes and sleep problems during menopause:

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs): These antidepressants can also help reduce hot flashes. Examples include paroxetine (Brisdelle), venlafaxine (Effexor XR), and desvenlafaxine (Pristiq).  

Gabapentinoids: Gabapentin (Neurontin, Gralise) and pregabalin (Lyrica) are anti-seizure medications that can also reduce hot flashes. Gabapentin can also improve sleep quality.  

Clonidine: This medication, typically used to treat high blood pressure, can also help reduce hot flashes.  

Fezolinetant (Veozah): This is a newer non-hormonal medication specifically for hot flashes. It works by blocking a pathway in the brain that helps regulate body temperature.  

It's important to note that these medications may have side effects, and their effectiveness can vary among individuals. It's crucial to discuss the benefits and risks of each medication with a healthcare provider to determine the most appropriate treatment plan.

 

  • Herbal remedies: Several herbal remedies have been traditionally used to manage hot flashes and sleep problems during menopause. However, it's important to note that the effectiveness and safety of these remedies can vary, and scientific evidence supporting their use may be limited. It's crucial to consult with a doctor before trying any herbal remedy, as they may interact with other medications or have potential side effects. This list is not intended as an endorsement of any herbal remedy or to treat any symptoms but instead is for informational purposes as to how menopause symptoms have been treated without using hormone therapy. Here are some commonly used herbal remedies for hot flashes and sleep problems during menopause:

Black cohosh: This herb has been traditionally used to relieve hot flashes, night sweats, and other menopausal symptoms. However, studies on its effectiveness have yielded mixed results.  

Red clover: Red clover contains isoflavones, which are plant-based compounds that can mimic estrogen's effects. Some studies suggest that red clover may help reduce hot flashes.  

Soy: Soybeans are rich in isoflavones and may help alleviate hot flashes and improve sleep quality.  

Evening primrose oil: This oil contains gamma-linolenic acid, which may help regulate hormone levels and reduce hot flashes. However, scientific evidence supporting its use is limited.  

Valerian root: Valerian root has been traditionally used to promote relaxation and improve sleep quality. It may be helpful for women experiencing sleep problems during menopause.  

Sage: Sage has been used to reduce hot flashes and night sweats. Some studies suggest that it may be effective in alleviating these symptoms.  

It's important to choose high-quality herbal supplements from reputable brands and follow recommended dosages. Be aware of any potential side effects or interactions with other medications. If you experience any adverse reactions, discontinue use and consult with a healthcare provider.

As women age, they start to experience changes and often these changes can be directly attributed to hormonal health. Estrogen in particular plays a vital role in women's health throughout their lives. Understanding estrogen levels and their fluctuations is essential for maintaining well-being and improving quality of life. ERT can be an effective treatment for managing menopausal symptoms and preventing bone loss, but it is important to discuss the benefits and risks with a healthcare provider to determine if it is appropriate.   For more information visit us online or call to schedule an appointment to speak with our physician Dr. Timothy W. Mackey.



Thursday, February 6, 2025

Managing Menopause Symptoms Through Hormone Therapy

From Perimenopause to Post-Menopause: What to Expect and How to Cope

Understanding Symptoms and Treatment Options for Women

Menopause is a natural biological process that marks the end of a woman's reproductive years. It's a significant transition, often accompanied by various physical and emotional changes. Understanding what menopause is and the available treatment options can empower women to manage this phase of life comfortably.


What is Menopause?

Menopause is officially diagnosed when a woman has gone 12 consecutive months without a menstrual period. This typically occurs between the ages of 45 and 55, with the average age being 51 in the United States.

The journey to menopause, known as perimenopause, can begin several years earlier. During this time, the ovaries gradually produce less estrogen and progesterone, leading to irregular periods and other symptoms.



Some women have no or mild menopausal symptoms and may even feel relieved when they no longer need to worry about periods or getting pregnant. For other women, the menopausal transition can bring various symptoms, including hot flashes, night sweats, trouble sleeping, joint and muscle discomfort, pain during sex, low sex drive, moodiness and irritability, forgetfulness, difficultly concentrating, or a combination of these.

Women who are concerned by menopausal symptoms should talk with a doctor about lifestyle changes. There are treatments available to help with symptoms of menopause, like hormone therapy, medication or lifestyle adjustments.


 

Common Symptoms of Menopause

The decrease in hormone levels during perimenopause and menopause can cause a range of symptoms, varying in intensity and duration from woman to woman. Some of the most common symptoms include:

  • Changes in menstruation: This is often the first noticeable sign, with periods becoming irregular, heavier or lighter, or shorter or longer.
  • Hot flashes: These sudden feelings of warmth, often accompanied by sweating and flushing, can disrupt daily life and sleep.
  • Night sweats: Hot flashes occurring at night can lead to excessive sweating and sleep disturbances.
  • Sleep problems: Difficulty falling asleep or staying asleep is common due to hormonal fluctuations and night sweats.
  • Vaginal dryness: Reduced estrogen levels can cause vaginal dryness, leading to discomfort during intercourse.
  • Mood changes: Some women experience mood swings, irritability, anxiety, or depression during this time.
  • Other physical changes: These may include weight gain, changes in skin elasticity, and increased risk of urinary tract infections.


How to Treat Menopause Symptoms

While menopause is a natural process, its symptoms can significantly impact a woman's quality of life. Fortunately, several treatment options are available to help manage these symptoms:

Hormone therapy (HT): This involves replacing the hormones estrogen and sometimes progesterone to alleviate symptoms like hot flashes, vaginal dryness, and sleep problems. HT is a personalized treatment with potential risks and benefits that should be discussed with a healthcare provider.

Types of Hormone Therapy

Hormone therapy for women is available in a few primary forms:

  • Estrogen Therapy (ET): This treatment involves taking estrogen alone, typically in a low dose. It is available in various forms, including patches, pills, creams, vaginal rings, gels, and sprays. However, estrogen alone is only recommended for individuals who have had a hysterectomy, as using it without a progestogen increases the risk of uterine complications.
  • Estrogen-Progestogen Therapy (EPT): Also known as combination therapy, this treatment includes both estrogen and a progestogen, which can be either natural progesterone or a synthetic progestin. This therapy is necessary for individuals who still have their uterus to help protect against uterine lining complications.
  • Testosterone Therapy: Testosterone for women is sometimes included in hormone replacement therapy (HRT) to address symptoms of low testosterone, which naturally declines with age or due to medical conditions. While estrogen and progesterone are the primary hormones in female HRT, testosterone supplementation can help improve energy levels, libido, mood, and muscle mass. It is often prescribed in low doses through creams, gels, or injections. However, therapy must be carefully monitored to avoid side effects such as acne, hair growth, or voice changes.

Hormone therapy carries potential risks, so it's essential to consult your healthcare provider to determine if it's a suitable option based on your health history, age, and individual needs.

 


Medications: Certain medications can help manage specific symptoms, such as antidepressants for mood changes or medications to improve sleep.

Lifestyle adjustments: Making healthy lifestyle choices can significantly ease menopause symptoms. This includes:

Maintaining a healthy diet: Focus on fruits, vegetables, whole grains, and lean protein. Foods to try include beans, soybeans, lentils, chickpeas to name a few.

Regular exercise: Engage in regular physical activity to improve overall health and reduce symptoms.

Stress management: Practice relaxation techniques like yoga, meditation, or deep breathing exercises.

Getting enough sleep: Aim for 7-8 hours of quality sleep per night.

Avoiding triggers: Identify and avoid triggers that worsen hot flashes, such as spicy foods, alcohol, or caffeine.

There are several nonhormonal prescription options available from your healthcare provider which may be able to help manage some of the symptoms of menopause. These may include:

  • Birth control pills to regulate hormone levels.
  • Antidepressants (SSRIs and SNRIs) to help with mood swings and hot flashes.
  • Gabapentin (a seizure medication) or fezolinetant to alleviate hot flashes.
  • Oxybutynin, typically used for overactive bladder, can also reduce hot flashes.
  • Vaginal creams and lubricants to relieve vaginal dryness.

Consult your healthcare provider first to determine if nonhormonal medications are suitable for your symptoms based on your medical history and unique needs.



Health Risks Associated with Menopause

Following menopause, the likelihood of developing conditions such as osteoporosis and cardiovascular disease rises due to declining estrogen levels. Your healthcare provider may monitor your health closely to assess potential risks and recommend appropriate treatments if necessary.

Osteoporosis

Osteoporosis occurs when bone density decreases, making bones more fragile and prone to fractures. Estrogen plays a crucial role in maintaining bone strength by signaling bone cells to slow down breakdown. On average, individuals lose about 25% of their bone mass from menopause to age 60. Healthcare providers may recommend bone density testing (bone densitometry) to assess calcium levels and bone health over time.

Cardiovascular Disease

The risk of cardiovascular disease increases post-menopause due to factors such as:

  • Reduced estrogen levels.
  • Elevated blood pressure.
  • Lifestyle choices like smoking, alcohol consumption, and poor diet.
  • Decreased physical activity, which may contribute to high cholesterol and other health concerns.

Maintaining a healthy lifestyle and seeking regular medical evaluations can help mitigate these risks.

 


Seeking Professional Guidance

It's crucial for women experiencing menopause symptoms to consult with a healthcare provider experienced in HRT for women. They can assess individual needs, discuss treatment options, and help create a personalized plan to manage symptoms effectively.

Remember: Every woman's experience with menopause is unique. By understanding the process, recognizing the symptoms, and exploring available treatments, women can navigate this transition with confidence and maintain a healthy, fulfilling life. To schedule a free initial consultation call or text us at 561-277-8260 or email us at info@novagenix.org



Tuesday, January 28, 2025

Commercial vs. Compounded Testosterone: How to Choose the Right TRT Option

Deciding on Testosterone Replacement: Commercial vs. Customized Options


Testosterone Replacement Therapy  (TRT) has become a common remedy for men facing symptoms of low testosterone, ( male andropause ) such as reduced libido, persistent fatigue, and erectile challenges. Men dealing with male andropause or hypogonadism are increasingly seeking diagnosis and treatment. When exploring TRT, it’s important to understand the differences between commercially manufactured products and customized (compounded) formulations to determine which approach best meets individual needs.


Production and Regulatory Oversight

Commercial Testosterone:
Major pharmaceutical companies produce commercial testosterone under strict FDA guidelines. These products are manufactured on a large scale using automated processes that include extensive testing to ensure consistent potency, purity, and safety. This rigorous quality control reassures patients about the reliability of these medications. For example:

  • AbbVie produces AndroGel, a well-known testosterone gel.
  • Endo Pharmaceuticals offers products such as Testim, Fortesta, and Testopel.
  • Pfizer manufactures Depo-Testosterone, an injectable form.
  • Allergan makes Androderm, a transdermal patch.
  • Antares Pharma, Clarus Therapeutics, and Aytu BioScience also contribute to the market with products like Xyosted, Jatenzo, and Natesto respectively.

Customized (Compounded) Testosterone:
In contrast, compounded testosterone is tailored to the patient by licensed pharmacists in specialized compounding pharmacies. Although these pharmacies adhere to specific regulatory standards and undergo periodic inspections by state agencies, the oversight is less stringent compared to FDA-approved products. This approach, however, allows for greater personalization to match the unique requirements of each patient while being under the influence of  health department regulatory agencies ensuring safety.



Formulation Flexibility

Standardized Options:
Commercial brands typically offer a set range of formulations, including injectables (like testosterone cypionate or enanthate), gels, and patches. These options—such as AndroGel, Testim, Axiron, and Fortesta—are convenient for many, though they may not suit every individual’s needs they provide flexibility to help a patient decide what the best testosterone to take for TRT for them is.

Personalized Formulations:
Compounded testosterone provides enhanced flexibility, allowing for adjustments in dosage strength, the type of ester used, and even the base oil (for instance, sesame or grapeseed oil). This customization can be especially beneficial for patients with specific sensitivities or preferences. Options include:

  • Injectable Solutions: Customizable esters and oils that align with the patient’s schedule and comfort.
  • Topical Applications: Testosterone creams, gels or lotions formulated in various concentrations to accommodate skin sensitivities.
  • Pellet Implants: Tailored pellets designed for sustained hormone release over several months.
  • Other Forms: Less common options like oral tablets or nasal sprays.

This versatility often makes compounded testosterone a more attractive choice for those who require a personalized approach.


Benefits and Considerations

Both commercial and compounded testosterone aim to alleviate the symptoms associated with low testosterone and improve overall quality of life. However, compounded formulations offer specific advantages:

  • Customized Dosing: Allows for precise adjustments based on individual responses and lab results.
  • Alternative Ingredients: Provides options for patients who might be allergic or sensitive to certain ingredients found in commercial products.
  • Enhanced Convenience: Tailored administration schedules and formulations can improve treatment adherence.

Cost and Insurance Implications

Financial considerations play a critical role in selecting a TRT option.

  • Commercial Products: Often covered by insurance, though coverage details may vary by product, dosage, and the specific requirements set by the insurance provider.
  • Compounded Medications: Generally not covered by insurance, meaning patients may face higher out-of-pocket expenses. However, many specialized hormone replacement clinics offer all-inclusive programs that can help manage costs while providing expert care.

Safety and Monitoring

Both treatment options require careful monitoring.

  • Commercial Medications: Benefit from rigorous  FDA oversight, ensuring a high standard of quality and safety.
  • Customized Formulations: Depend on the reputation and reliability of the compounding pharmacy; selecting a trusted provider is crucial.
  • Potential Side Effects: Both options can have side effects such as acne, mood fluctuations, increased red blood cell counts, and cardiovascular risks, making regular check-ups with a healthcare provider essential to avoid or mitigate the potential for Allergies, sensitivities or other unwanted condition.

Making the Right Choice

Deciding between commercial and compounded testosterone should be a collaborative process involving the patient and their healthcare provider. Key factors to consider include:

  • Personal Needs: Consider allergies, lifestyle, and preferred administration methods.
  • Medical Requirements: Determine if a personalized formulation is necessary to address specific health concerns.
  • Cost and Insurance: Evaluate affordability and understand the details of insurance coverage.
  • Quality Assurance: Ensure any compounding pharmacy chosen has a strong track record for quality and safety.

Commercial testosterone offers reliability and standardization, while compounded options provide the flexibility to fine-tune treatment. With professional guidance, patients can choose the option that best supports their health and well-being.

For further information on testosterone therapy, testing, diagnosis, and treatment options, visit www.NovaGenix.org or call/text 561-277-8260 to schedule a free consultation.

Testosterone Therapy Simplified: Weighing Commercial Brands vs. Compounded Options