Testosterone

Important Safety Information

• Administration caution: Use appropriate formulation and route (e.g., injection, transdermal, buccal, etc.).
• Monitoring: Regularly monitor serum testosterone levels, hemoglobin/hematocrit, liver function, lipid profile, and PSA (prostate-specific antigen) in men.
• Risk of abuse/misuse: Testosterone can be misused for performance enhancement, leading to serious cardiovascular and psychiatric side effects.
• Pediatric use: Risk of premature closure of growth plates in children.
• Transference risk: With topical formulations, accidental exposure to others (e.g., partners, children) can cause virilization.

Indications/Use

• Primary hypogonadism (congenital or acquired) in men.
• Hypogonadotropic hypogonadism (congenital or acquired) in men.
• Delayed puberty in adolescent males (selected cases, typically short-term).
• Palliative treatment of certain breast cancers in postmenopausal women (rarely used today).

Contraindications

• Known or suspected prostate cancer or breast cancer in men.
• Pregnancy and breastfeeding.
• Hypersensitivity to testosterone or any component of the formulation.
• Serious cardiac, hepatic, or renal disease (risk of edema with testosterone therapy).
• Elevated hematocrit (>54%).
• Untreated/uncontrolled sleep apnea.

Side Effects

Common side effects include:

• Common: Acne, oily skin, increased hair growth, gynecomastia (can occur with aromatization), mood changes, hot flashes/night sweats (can occur with aromatization).
• Cardiovascular: Hypertension.
• Hematologic: Polycythemia (increased hematocrit).
• Hepatic: Liver dysfunction, hepatotoxicity (more common with oral 17-alpha alkylated androgens).
• Reproductive: Reduced sperm production (infertility), testicular atrophy, priapism/erection changes.
• Other: Poor sleep, sleep apnea worsening, edema, nipple sensitivity.

Frequently Asked Questions

1. What is testosterone? Testosterone is a hormone primarily produced in the testes in men and, to a lesser extent, in the ovaries in women. It plays a crucial role in the development of male reproductive tissues, secondary sexual characteristics (such as muscle mass, bone density, and body hair), and overall well-being. In both men and women, testosterone is vital for maintaining muscle strength, energy levels, and libido.

2. How is testosterone administered? Testosterone can be administered through various methods, including:

   • Cream: Topical testosterone cream is applied to the skin, usually on areas with minimal hair, such as the inner arms or abdomen, but primarily the testicles. The hormone is absorbed through the skin and into the bloodstream over time.
   • Injection: Testosterone injections are typically administered intramuscularly (into the muscle) or subcutaneously (under the skin). The frequency of injections can vary, with some protocols requiring weekly or bi-weekly doses.
   • Note: In most cases, we will be prescribing via the subcutaneous route.
   • Oral Dissolvable Tablets (ODTs): These are typically absorbed into the cheek/gums with a little water once to twice daily.
   • We also offer:
     • Enclomiphene:
       • The main indications for using off-label enclomiphene are patients who:
         • Have low testosterone with correlating symptoms
         • Want to preserve fertility
         • Want to avoid testosterone products, including injections
         • Have “secondary hypogonadism” (not due to causes related to high prolactin levels) with low testosterone and low-normal or low FSH/LH
     • Anastrozole:
       • Aromatase inhibitors, like the orally administered anastrozole, can help treat and reduce elevated estradiol levels in men with low testosterone. The goal is to decrease estradiol levels to within the normal male range and reduce associated symptoms of elevated estrogen (hot flashes, night sweats, irritability/mood lability, poor sleep, bloating/water retention, erection changes, or midsection weight gain). When necessary, this can be co-administered with testosterone.

3. Why is it important to move injection sites? Rotating injection sites is essential to prevent tissue damage, irritation, or the development of scar tissue at the injection site. Repeated injections in the same area can lead to complications such as infections or lumps, making absorption of testosterone less effective.

4. What are the side effects of testosterone? Common side effects of testosterone therapy may include acne, oily skin, hair loss, increased body hair, mood changes, increased estradiol levels, and testicular atrophy. More serious side effects can include an increase in red blood cell count, sleep apnea, or an enlarged prostate in men. Testosterone therapy may increase the risk of increased blood pressure. It's important to monitor these effects with your healthcare provider to adjust treatment as necessary.

5. What are the benefits of testosterone? Testosterone replacement therapy can provide several benefits, including improved energy levels, increased muscle mass and strength, enhanced libido, improved mood and mental clarity, and better overall well-being. These benefits can significantly improve the quality of life for individuals with low testosterone levels who have associated symptoms.

6. What is the negative feedback loop? The negative feedback loop refers to the body's natural regulatory mechanism that maintains hormone balance. When testosterone levels rise due to hormone replacement therapy, the hypothalamus and pituitary gland may reduce the natural production of testosterone. This can lead to a reliance on therapy for maintaining testosterone levels and may affect one's ability to get their partner pregnant.

7. How does testosterone affect fertility? Testosterone therapy can negatively impact fertility by suppressing the natural production of sperm. This is due to the aforementioned negative feedback loop, where the increased testosterone levels signal the body to reduce the production of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), both of which are crucial for sperm production.

8. What is meant by transference when someone applies topical testosterone? Transference refers to the unintentional transfer of testosterone from one person to another through direct skin contact. If someone has applied topical testosterone and then touches another person, the hormone can transfer to that person's skin, potentially causing unwanted effects. To prevent this, it's important to wash hands thoroughly after application and avoid skin contact with others in the area where the cream was applied. In addition, testosterone can be transferred by vaporization for 4–6 hours after application. Thus, it is essential to avoid contact or proximity with small children after application.

9. What increases PSA levels? Prostate-specific antigen (PSA) is a protein produced by the prostate gland, and its levels in the blood can be an indicator of prostate health. While elevated PSA levels can be associated with prostate cancer, they can also be influenced by several other factors:

   1. Benign prostatic hyperplasia (BPH): An enlarged prostate, which is common in older men, can cause elevated PSA levels. BPH is a non-cancerous condition but can still lead to an increase in PSA.
   2. Prostatitis: Inflammation or infection of the prostate gland, known as prostatitis, can cause a significant rise in PSA levels. This condition can be acute or chronic and may present with symptoms such as pelvic pain, urinary issues, or discomfort.
   3. Recent ejaculation: Sexual activity, particularly ejaculation, can temporarily elevate PSA levels. It is recommended to avoid sexual activity for 24 to 48 hours before a PSA test to avoid this influence.
   4. Prostate manipulation: Any manipulation of the prostate, such as during a digital rectal exam (DRE) or recent urinary catheterization, can lead to a temporary increase in PSA levels.
   5. Age: PSA levels naturally tend to increase with age, even in the absence of prostate cancer or other prostate conditions.
   6. Testosterone therapy: While testosterone therapy can lead to an increase in PSA levels due to the hormone's effects on prostate tissue, this increase is usually within a normal range. However, significant or rapid rises in PSA during testosterone therapy warrant further investigation to rule out other causes.
   7. Prostate cancer: Elevated PSA levels can be an indicator of prostate cancer, particularly when the increase is significant or when it occurs rapidly. However, PSA is not a definitive marker for cancer, and elevated levels can occur for benign reasons as well.