A-057 Testosterone pellets: Their impact on laboratory results

Abstract Background In our laboratory, we are currently observing elevated serum testosterone (To) values in women. This prompted us to review the causes in the medical record (MR). Physiologically, To decreases with age to values that are undetectable by immunoassays. The use of To pellets has become popular to improve libido, cognition, muscle strength, and to prevent aging. The role of exogenous To in women has contradictory results, although those who use it express well-being. The values observed in these patients, generally postmenopausal, exceed the target values for their age, causing concern since there are no studies about their long-term safety. Objective: To evaluate the elevated To values in women and their causes and to identify whether they correspond to the use of To pellets. Methods A retrospective cross-sectional study was conducted that included women with To above the reference range (RR) between April 2023 and January 2025. To values were searched in the computer system by filtering the required values, with this data possible causes were investigated in the MR. To values were measured by ECLIA- Cobas e801 (Roche), analytical measurement range between 0.025 and 15 ng/ml, LD: 0.025 ng/mL, LOQ: 0.12 ng/mL, RR for postmenopausal women: 0.12 to 0.41 ng/mL. Results Of the 87 women with high To values concerning the RR, it was found that: 22 corresponded to the use of To Pellets, 44 Transgender, 4 PCOS, 1 Gonadal Dysgenesis (GD), 2 Ovarian Tumor (OT) , 2 Congenital Adrenal Hyperplasia (CAH), 1 Benign Pelvic Pathology (BPP), 1 Ovarian Cyst (OC), 1 Premature Ovarian Failure (POF), 1 Estrogen Treatment (ET) and 8 without data in the HC (WD). In patients with Pellets, the To values found according to age were: To (ng/mL) /age (years): 10.70/63; 4.51/48; 2.02/51; 4.40/51; 1.73/49; 1.68/58; 1.05/50; 2.96/51; 3.4/52; 4.41/55; 2.04/59; 2.06/51; 8.99/49; 7.1/49; 3.51/55; 4.54/50; 3.45/50; 2.98/42; 4.63/54; 3.95/51; 2.73/41; 2.87/51. (Graph 1) Conclusion We observed that the causes of the elevated To values in the evaluated women were diverse. We found that the patients carrying To Pellets were all postmenopausal with ages between 41 and 63 years and all showed supraphysiological values of serum To according to the ranges established for their age. These results demonstrate that despite the limited evidence from studies on the safety, efficacy, and long-term adverse effects of To Pellets in this age group, we must consider that this replacement therapy is still used.