An open‐label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP 101

Summary We compared a novel 5% testosterone (T) cream (AndroForte 5, Lawley Pharmaceuticals, Australia) with a 1% T gel (Testogel, Besins Healthcare, Australia). Using an open‐label crossover design, subjects were randomized to one of two treatment sequences using either the T gel or T cream first in a 1 : 1 ratio. Each treatment period was 30 days with a 7–14 days washout period between them. On Days 1 and 30 of each treatment period blood was sampled at −15, −5 min, 0, 2, 4, 5, 6, 7, 8, 9, 10, 12 and 16 h post study drug administration. Sixteen men with established androgen deficiency aged between 29 and 73 years, who had undertaken a washout from prior testosterone therapy participated in the study. One subject failed to complete both arms and another was excluded post‐completion because of a major protocol violation. Bioequivalence was established based on key pharmacokinetic ( PK ) variables: AUC , C avg , C max , T max , % fluctuation (with and without baseline correction) for the two formulations of testosterone on Day 1 and Day 30. The ratio and 90% CI of AUC 0.99 (0.86–1.14), C max 1.02 (0.84–1.24) and C avg 0.99 (0.86–1.14) for T cream/T gel were within the predetermined bio‐equivalence criteria of 80% to 125% at Day 30. There were no statistically significant differences between secondary biochemical markers: serum dihydrotestosterone ( DHT ), oestradiol (E2), sex hormone‐binding globulin ( SHBG ), luteinizing hormone ( LH ) and ( FSH ). The two testosterone formulations were shown to be bioequivalent.