Testosterone Replacement Therapy (TRT) Overview
Testosterone Replacement Therapy (TRT) is one of the most used hormonal treatments for men with low testosterone levels that is known as Hypogonadism. As men age, testicular function tends to decline so testosterone production decreases in addition to the increase of “Hormone Binding Globulin” which is a protein that binds to free testosterone resulting in a decrease in testosterone bioavailability.
Hypogonadism is a common clinical condition among older men, it’s called “androgen deficiency” or “andropause” and in order to start Testosterone Replacement Therapy (TRT), the presence of signs or symptoms of hypogonadism and low testosterone levels must exist.
Low testosterone levels cause significant clinical signs:
- Loss of muscle and bone mass.
- Hair loss.
- Depressed mood.
- Erectile dysfunction.
- Decreased libido and sexual desire.
- Infertility.
- Hot flashes.
Types of Testosterone Replacement Therapy
Testosterone Replacement Therapy (TRT) is classified according to the route of administration:
- Oral administration is the least successful route as the hormone will be destroyed by the liver because hormones are protein in nature, known as “First Pass Metabolism” while
- Buccal route delivers testosterone directly to circulation through the gums so it bypasses “First Pass Metabolism” and it’s one of the most well-tolerated routes.
- Nasal actuation is the latest route discovered and approved by FDA which allows self-administration through the nasal mucosa.
- Subdermal injections are effective preparations in compliance and infrequent doses but induce skin adverse effects.
- Transdermal preparations provide maximum absorption through the skin at specific sites of thin skin.
- Intramuscular preparations require close monitoring after injection due to serious side effects.
Testosterone Replacement Therapy Benefits
Testosterone Replacement Therapy (TRT) main goal is to restore serum levels of free testosterone within a healthy range and to improve symptoms of hypogonadism. Testosterone has many benefits including increased bone density and mass, red blood cell production, sexual function, muscle strength and cardio-protection.
- Improved sex drive and performance due to increased serum-free testosterone that is responsible for erectile function and activity.
- Increases bone mineral density as testosterone increases “Osteoblasts” activity which are responsible for bone development and remodeling.
- Muscle mass and strength are increased through the testosterone stimulation of IGF-1 (Insulin Growth Factor-1) causing an increase in muscle protein synthesis.
- Improved body composition by decreasing fat mass and increasing lean body mass.
- Energy and mood elevation due to the improved quality of life by decreasing the probability of depressive episodes and increasing hemoglobin production by “Erythropoiesis” which produces hemoglobin from stem cells.
- Decreased risk of type 2 diabetes, metabolic syndrome, and cardiovascular events as low levels of testosterone contributes to increased mortality due to cardiovascular diseases.
Testosterone Replacement Therapy Risks
TRT risks depend on variable aspects such as age, medical condition, genetics, and life circumstances.
- Benign Prostate Hyperplasia (BPH) as testosterone increases the prostate volume leading to the increase of Prostate Specific Antigen (PSA) which leads to BPH.
- Worsen the outcomes in patients with diagnostic prostate cancer and high-risk patients due to androgens sensitivity to free testosterone.
- Hepatotoxicity and liver failure due to oral testosterone preparations (except testosterone undecanoate). Liver issues do not appear with intramuscular injections or transdermal routes.
- High hemoglobin levels produced due to free testosterone increases the risk of Polycythemia leading to myocardial infarction, deep vein thrombosis and stroke.
Who Shouldn’t Take Testosterone Replacement Therapy ?
- Testosterone Replacement Therapy is contraindicated for men who are seeking to father a child as it will disrupt the fetus hormonal axis.
- Prostatic carcinoma, nodules, and indurations.
- Breast cancer
- Prostate-specific antigen (PSA) elevation.
- Erythrocytosis (hematocrit value > 50%)
- Benign Prostatic Hyperplasia (BPH).
- Congestive heart failure.
Testosterone Replacement Therapy Duration
Duration of Testosterone Replacement Therapy (TRT) is related to different factors including testosterone preparation type, genomic and non-genomic effects.
The time course of TRT corresponds to the desired outcome as follows:
- Improved Sexual Performance after 3 to 6 weeks.
- Enhanced Erections in 6 months.
- Erythropoiesis (Red blood cell production) was observed after 3 months with a peak value at the 9th to 12th months.
- Effects on Lipids after 6 to 12 months.
- Glycemic Control after 3 to 12 months.
- Lean Body Mass after 3 months
- Bone Density after 6 months.
- The mentioned durations are required to observe the desired outcome, and maintenance doses are required for peak effects.
Testosterone Replacement Therapy Alternatives
- Clomiphene citrate: Selective estrogen receptor modulator (SERM), blocks estrogen receptors in the pituitary gland and hypothalamus.
- Aromatase inhibitors: Prevents estrogen biosynthesis from testosterone.
- Human chorionic gonadotropin: Increases intra-testicular testosterone.
Is Testosterone Replacement Therapy FDA Approved?
Testosterone Replacement Therapy (TRT) preparations are approved by the FDA for men having low levels of testosterone in addition to medical conditions such as:
- Primary Hypogonadism (Testicular dysfunction).
- Secondary Hypogonadism (Adrenal/Pituitary gland disease).
How Can You Get Testosterone Replacement Therapy ?
- Testosterone Replacement Therapy is contraindicated for men who are seeking to father a child as it will disrupt the fetus hormonal axis.
- Prostatic carcinoma, nodules, and indurations.
- Breast cancer
- Prostate-specific antigen (PSA) elevation.
- Erythrocytosis (hematocrit value > 50%)
- Benign Prostatic Hyperplasia (BPH).
- Congestive heart failure.
Who Shouldn’t Take Testosterone Replacement Therapy ?
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- Testosterone Replacement Therapy (TRT)
- Bioidentical Hormone Replacement Therapy (BHRT) through Atrevis Hydrogel® advanced base for topical testosterone preparations.
Atrevis® provides an advanced topical hydrogel base that is designed specifically for enhanced testosterone absorption and delivery through the skin of male patients.
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Unique delivery system to deliver the testosterone through the skin includes a hydrogel polymer network and three naturally derived skin-permeation enhancers.
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References
- Risks of testosterone replacement therapy in men
- The benefits and risks of testosterone replacement therapy: a review
- Pharmacology of testosterone replacement therapy preparations
- Alternatives to testosterone replacement: testosterone restoration
- Onset of effects of testosterone treatment and time span until maximum effects are achieved
- ATREVIS HYDROGEL® (30-4986)
