Testosterone Pellets in Women: Revisiting Safety and Clinical Outcomes
Abstract
Testosterone is the most abundant biologically active gonadal steroid in women, yet its therapeutic role remains controversial. Current guidelines restrict its use to hypoactive sexual desire disorder (HSDD) with transdermal formulations, while subcutaneous pellets are used off-label in clinical practice despite unresolved concerns about pharmacokinetics, efficacy, and safety. The objective of this study is to critically evaluate the pharmacokinetics, clinical efficacy, and safety of subcutaneous testosterone pellets in peri- and postmenopausal women. A structured narrative review was conducted using PubMed/MEDLINE, covering studies published from January 1980 to August 2025. Other databases were not systematically searched. Search terms included "testosterone", "pellets", "implants", "subcutaneous", "women", and "menopause", combined with Boolean operators. Eligibility criteria comprised original pharmacokinetic or clinical studies in women, defined by STRAW+10 when available, reporting outcomes on pharmacokinetics, efficacy, or safety. Narrative synthesis was chosen due to heterogeneity in design, dosing, comparators, and outcome definitions. From 455 records, 38 studies were included. Pellets provided sustained release over four to six months with supraphysiologic early peaks (>100-250 ng/dL) and wide interindividual variability. The only randomized controlled trial showed improved sexual activity, orgasm, and satisfaction at 24 weeks with testosterone plus estradiol…
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