Laboratory Monitoring for Women on Androgel (Testosterone Gel)
Women on testosterone therapy with Androgel require monitoring of serum testosterone levels at 2-3 months after initiation or dose adjustment, then every 6-12 months once stable, along with periodic assessment of hematocrit, hemoglobin, and liver function tests. 1, 2
Initial Pre-Treatment Laboratory Assessment
Before initiating Androgel in women, baseline laboratory values should be documented:
- Morning total testosterone levels measured on at least two separate occasions to confirm hypogonadism, though normative data for women across the lifespan remain inadequately defined 2, 3
- Free testosterone by equilibrium dialysis in addition to total testosterone, particularly when total testosterone is borderline 1
- Baseline hematocrit or hemoglobin to monitor for potential erythrocytosis during treatment 1, 2
- Liver function tests as a baseline for comparison during ongoing therapy 2
Ongoing Monitoring During Treatment
Testosterone Level Monitoring
- Measure testosterone levels at 2-3 months after treatment initiation or any dose adjustment to ensure adequate therapeutic levels 1, 2
- Once stable levels are confirmed on a given dose, monitor every 6-12 months 1
- For women on testosterone gel, testosterone levels can be measured at any time after 2-3 months of stable therapy, as transdermal preparations provide relatively stable day-to-day levels 1
- Target mid-normal testosterone levels appropriate for the patient's affirmed gender identity 4
Hematologic Monitoring
- Monitor hematocrit and hemoglobin periodically throughout treatment 2, 5
- Withhold treatment if hematocrit exceeds 54% and consider phlebotomy in high-risk cases 1
- Erythrocytosis is a known risk of testosterone therapy, with injectable forms carrying higher risk than transdermal preparations 1
- Hemoglobin typically increases during testosterone therapy, with correction of anemia observed in some patients 5, 6
Hepatic Monitoring
- Monitor liver function tests periodically during ongoing testosterone therapy 2
- Testosterone replacement therapy may be associated with transient elevations in liver enzymes that are usually self-limited 4
Laboratory Value Interpretation in Transgender Patients
For transgender men (female-to-male) on testosterone therapy:
- After more than 1 year of testosterone therapy, interpret laboratory values based on male reference ranges 4
- For those newly initiated on testosterone (less than 1 year), laboratory values may be transitional and should be interpreted with caution, understanding that values will shift over time 4
- Creatinine reference ranges should be interpreted based on affirmed gender after 1 year of therapy, as testosterone increases lean body mass by approximately 4 kg 4
- Electrolyte monitoring is important, particularly if spironolactone was previously used, as sodium, potassium, and blood urea nitrogen may fluctuate 4
Additional Monitoring Considerations
Estradiol Monitoring
- Routine estradiol monitoring is NOT recommended in asymptomatic patients on testosterone therapy 7
- Check estradiol levels only if patients develop new breast symptoms, including breast pain, tenderness, or nipple discomfort 7
- Estradiol levels commonly increase during testosterone therapy due to peripheral aromatization, but symptomatic gynecomastia is uncommon despite rising estradiol 7
Lipid Monitoring
- Monitor lipid concentrations periodically, as testosterone therapy may improve lipid profiles, including reductions in triglycerides and improvements in HDL cholesterol 1, 2
Metabolic Monitoring
- Assess fasting plasma glucose and insulin resistance markers, as testosterone therapy can improve glycemic control and metabolic parameters 1
Critical Pitfalls to Avoid
- Do not skip baseline laboratory assessment before initiating therapy, as this prevents proper monitoring for adverse effects 1, 2
- Do not ignore mild erythrocytosis (hematocrit 50-52%), particularly in patients with cardiovascular risk factors, as even modest elevations increase blood viscosity and thrombotic risk 1
- Do not continue full-dose testosterone when hematocrit exceeds 54%, as this is an absolute indication to withhold therapy 1
- Do not measure testosterone levels at inappropriate times relative to application, as this may lead to inaccurate dose adjustments 1
- Do not assume laboratory reference ranges without considering duration of testosterone therapy and affirmed gender in transgender patients 4
Special Considerations for Female-to-Male Transgender Patients
- Screen for liver abnormalities and polycythemia before initiating high-dose androgen therapy in female-to-male transgender patients 4
- Duration of testosterone therapy, dose, and route of administration should be recorded when interpreting laboratory values 4
- For patients who have stopped testosterone therapy, laboratory values typically reflect their sex assigned at birth within 3 months of discontinuation 4