(046) Long-term Testosterone Pellet Insertion in Women with Low Libido Shows No Evidence of Erythrocytosis and a Minimal Side Effect Profile

Abstract Introduction Testosterone therapy for low libido in women has become more prevalent over recent years. While numerous testosterone formulations exist and have been studied in women, there has been little data assessing the safety and efficacy of subcutaneous testosterone pellet use in this population. Objective The aim of this study was to understand the biochemical effects and side effect profile of female patients who underwent testosterone pellet insertion by a single provider at an academic institution. Methods An Institutional Review Board approved retrospective chart review of all female patients undergoing testosterone pellet insertion from 2009-2022 was undertaken. Women taking 75 mg and 100 mg testosterone pellets were identified, and separately analyzed for biochemical and clinical data. Analysis of variance was performed to determine statistical significance of laboratory values over duration of testosterone pellet insertion. Results A total of 220 separate pellet insertion sessions were undertaken amongst the two cohorts. In the 75 mg cohort, the average number of pellets inserted per session was one. The average time between pellet insertion was 4.7 months (Standard error (SE) 0.1) over a five year period. There was no statistically significant change in testosterone trough levels over the duration of treatment (P=0.5105). There was also no statistically significant change in hematocrit levels from baseline (P=0.9696). In addition, no statistically significant change in systolic blood pressure was noted (P=0.8798). None of the patients in this cohort reported new or worsening acne. One patient reported mild increased facial hair growth. Two out of 19 (10.5%) patients reported vaginal bleeding during the study period, but both were also on systemic estrogen therapy at the time. In the 100 mg cohort, the average number of pellets inserted per session was one. The average time between pellet insertion was 4.3 months (SE 0.1) over an 18 month period. There was a statistically significant rise in testosterone trough levels over the duration of treatment (P=0.0168). There was no statistically significant change in hematocrit levels from baseline (P=0.7805). There was no statistically significant change in systolic blood pressure (P=0.7030). Two patients in this cohort were started on new blood pressure medications during the treatment course. None of the patients in this group reported new or worsening acne, changes in facial hair growth, or vaginal bleeding. Conclusions In both the 75 mg and 100 mg cohorts, testosterone pellet insertion lead to steady testosterone levels based on trough data, with a statistically significant rise amongst the 100mg cohort, and without any statistically significant rise in erythrocytosis rates, which is commonly seen with exogenous testosterone administration in the male population. In addition, no statistically significant changes in systolic blood pressure were noted in either cohort, along with minimal other side effects. This data suggests a relatively safe biochemical profile for regulated testosterone pellet administration in women with low libido, with a minimal side effect profile. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific