title: 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 LP101.
abstract: 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.
authors.affiliation: Adelaide University, Adelaide, SA, Australia.
authors.forename: G A
authors.initials: GA
authors.lastname: Wittert
authors.affiliation: New England Research Institutes (NERI), Watertown, MA, USA.
authors.forename: R W
authors.initials: RW
authors.lastname: Harrison
authors.affiliation: Lawley Pharmaceuticals, Perth, WA, Australia.
authors.forename: M J
authors.initials: MJ
authors.lastname: Buckley
authors.affiliation: JWCS, Sydney, NSW, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Wlodarczyk
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000728:Androgens / Q000172:deficiency*; D018592:Cross-Over Studies; D013196:Dihydrotestosterone / Q000097:blood; D004958:Estradiol / Q000097:blood; D005640:Follicle Stimulating Hormone / Q000097:blood; D005782:Gels; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D008875:Middle Aged; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D063465:Skin Cream / Q000627:therapeutic use*; D013739:Testosterone / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D013810:Therapeutic Equivalency
chemical_list: D000728:Androgens; D005782:Gels; D012738:Sex Hormone-Binding Globulin; D013196:Dihydrotestosterone; D013739:Testosterone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone
keywords: bioequivalence; male hypogonadism; pharmacokinetics; testosterone; transdermal testosterone