Testosterone Therapy: Treatment Options, Monitoring, and Safety

Introduction

This article reviews the main testosterone therapy options for men and women, explains how treatment is monitored, outlines potential side effects, and discusses cost and safety considerations.

In Part 1 of this series, we explored what testosterone does in the body, symptoms of deficiency, and how to interpret laboratory testing. Once testosterone deficiency is identified, the next step is to select the right treatment, establish clear therapeutic goals, and implement structured monitoring to ensure the treatment is safe and effective.

Treatment Goals

The primary goals of testosterone therapy are to:

• Restore physiologic hormone levels, not push levels into supraphysiologic ranges. Your goal is to get you to the levels of a healthy young adult, NOT to become Mr. Olympia!
  
  
• Relieve symptoms and improve energy, libido, cognition, mood, sleep, and body composition.
  
  
• Support long-term health, including bone density, metabolic function, and cardiovascular health.
  
  
• Maintain safety through regular follow-up, appropriate labs, and dose adjustments as needed.
  

Achieving these goals depends on selecting the right delivery method for each patient’s lifestyle, medical history, and clinical needs.

Testosterone Therapy Options

There are multiple treatment options available for men and women. Each option has its own unique pros and cons.

For Men

For Women

• Transdermal creams or gels remain the most commonly used option. They allow for very low, physiologic dosing that can be titrated precisely.
  
  
• Low-dose injections (subcutaneous or intramuscular) are increasingly used for women as well. Doses are carefully individualized—much lower than those used for men—and are typically given once weekly or every 10–14 days. This approach can provide stable hormone levels, avoids transference risk associated with topical therapy, and is generally well tolerated when monitored appropriately.
  
  
• Pellets provide long-term delivery (3–5 months) and can be convenient. Gives a more consistent blood level of hormone. Dose cannot be changed once the pellets are inserted. The treatment of choice (in my opinion) on stable patients who care about convenience and cost is not as much of an issue.
  
  
• Oral testosterone is generally avoided in women due to hepatic effects and variable blood levels.
  
  
• Because no FDA-approved testosterone products are currently available for women in the U.S., compounded formulations or off-label dosing of male products are typically used under medical supervision.
  
  

Monitoring During Therapy

Regular monitoring ensures that therapy remains both effective and safe.

• Initial follow-up: 4-6 weeks after starting or adjusting therapy to check the peak levels, then trough levels 3 months after procedure for women, 6 months for men.
  
  
• Subsequent follow-up: Every 6 months in the first year, then every 6-12 months thereafter.
  
  

Recommended Laboratory Tests

Clinical Monitoring

Your medical provider should ask about the following symptoms or side effects:

• Libido, mood, energy, cognition
  
  
• Sexual function and sleep quality
  
  
• Physical changes (muscle mass, fat distribution, hair, skin)
  
  
• Potential side effects such as acne, irritability, hair growth or hair loss, or fluid retention
  
  

Dosing should be adjusted based on both labs and clinical symptoms, not just the lab numbers alone.

Safety Considerations

Men

• Erythrocytosis
  Testosterone can increase red blood cell production. Hematocrit should be monitored periodically, and therapy should be held or adjusted if hematocrit exceeds 50%.
  
  
• Prostate Health
  Current evidence shows no increased risk of prostate cancer with physiologic testosterone replacement, but ongoing monitoring is essential. If your PSA level is >3.0, a urological evaluation and clearance is recommended before starting therapy.
  
  
• Cardiovascular Health
  Physiologic testosterone replacement generally has neutral or beneficial cardiovascular effects, improving insulin sensitivity, lipids, and vascular function. Supraphysiologic dosing, however, should be avoided in high-risk individuals.
  
  

Women

• Androgenic Side Effects
  Excess dosing can lead to acne, oily skin, facial hair growth, scalp hair thinning, or voice deepening. These are uncommon with physiologic dosing and careful monitoring.
  
  
• Endometrial Protection
  If a woman is also on estrogen therapy and has an intact uterus, she must receive oral micronized progesterone for endometrial protection.
  
  

Managing Side Effects and Dose Adjustments

Signs of excessive dosing may include acne, irritability, oily skin, increased hair growth, elevated hematocrit, or voice changes (in women).
Signs of underdosing include persistent symptoms of deficiency despite therapy.

Dose adjustments should be made gradually and always guided by both lab values and the clinical picture.

Dangers of Excess Testosterone

While physiologic testosterone replacement is generally safe when properly monitored, excessive dosing—whether intentional or accidental—can lead to significant short- and long-term complications. These effects are dose-dependent and more likely when testosterone levels exceed the upper physiologic range.

Hormonal Suppression

High testosterone levels suppress the hypothalamic–pituitary–gonadal axis:

• Men: Decreased LH and FSH suppress endogenous testosterone production and spermatogenesis, potentially leading to infertility and testicular atrophy. Recovery can take months and sometimes requires medical intervention.
  
  
• Women: Excess testosterone can disrupt ovarian hormone production, leading to menstrual irregularities or amenorrhea.
  
  

Erythrocytosis

Excess testosterone stimulates red blood cell production, sometimes leading to an elevated hematocrit (>50%). This increases blood viscosity and raises the risk of thrombotic events such as stroke or blood clots. Regular hematocrit monitoring is essential, particularly in men.

Cardiovascular Risks

Physiologic replacement has neutral or beneficial cardiovascular effects, but supraphysiologic levels—especially in the context of anabolic steroid abuse—are linked to hypertension, dyslipidemia, left ventricular hypertrophy, arrhythmias, and, in extreme cases, myocardial infarction or sudden cardiac death.

Androgenic Side Effects

• Men: Acne, oily skin, gynecomastia (via aromatization), accelerated male-pattern baldness, irritability.
  
  
• Women: Acne, oily skin, hirsutism, scalp hair thinning, voice deepening (potentially permanent), clitoral enlargement, and menstrual disturbances.
  
  

Psychological and Behavioral Changes

Elevated testosterone can affect mood and behavior, occasionally causing irritability, agitation, insomnia, or mood swings. In cases of supraphysiologic anabolic steroid use, more severe effects such as aggression or dependency can occur.

Liver and Lipid Changes

Oral androgens can be hepatotoxic. Even with non-oral routes, excess testosterone can adversely affect lipid profiles, typically lowering HDL and raising LDL, potentially increasing long-term cardiovascular risk.

Prostate Effects (Men)

While physiologic testosterone does not increase prostate cancer risk, excessive or unmonitored dosing may raise PSA levels, stimulate prostate growth, or worsen lower urinary tract symptoms in men with benign prostatic hyperplasia.

⚠️ Key Point: The dangers of testosterone therapy are largely related to excessive or poorly monitored dosing. Physiologic, individualized therapy with appropriate follow-up is safe for most patients, but “more is better” is not true when it comes to hormones.

Cost Considerations

Summary

Testosterone therapy can be safe, effective, and life-changing when done correctly. Success depends on selecting the right delivery method, using physiologic doses, and monitoring both labs and symptoms carefully over time. Men and women have multiple options—including topical, injectable, and pellet therapies—and the best choice depends on individual goals, lifestyle, and medical history.

If you think you could have testosterone deficiency, schedule a consultation with a knowledgeable hormone optimization clinician like myself to determine which therapy is right for you.

References

1. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744.
   
   
2. Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol. 2018;200(2):423–432.
   
   
3. Handelsman DJ. Androgen Physiology, Pharmacology, Use and Misuse. In: Feingold KR, Anawalt B, Boyce A, et al, eds. Endotext [Internet]. MDText.com, Inc.; 2018.
   
   
4. Morgentaler A, Traish A. Shifting the paradigm of testosterone and prostate cancer: the saturation model and the limits of androgen-dependent growth. Eur Urol. 2009;55(2):310–320.
   
   
5. Sharma R, Oni OA, Gupta K, et al. Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J. 2015;36(40):2706–2715.
   
   
6. Davis SR, Baber R, Panay N, Bitzer J, Perez SC, Islam RM. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. Climacteric. 2019;22(5):429–434.
   
   
7. Glaser R, Dimitrakakis C. Reduced breast cancer incidence in women treated with subcutaneous testosterone: prospective 10-year cohort study. Maturitas. 2013;76(4):342–349.
   
   
8. Snyder PJ. Hypogonadism in elderly men—what to do until the evidence comes. N Engl J Med. 2004;350:440–442.
   
   
9. Saad F, Gooren L, Haider A, Yassin A. A dose–response study of testosterone on sexual dysfunction and on features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl. 2008;29(1):102–105.
   
   
10. Davis SR, Wierman ME, Miller KK, Panay N. Androgen therapy in women: a reappraisal: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(10):3489–3510.