Oestrogen versus androgen in hormone-replacement therapy for complete androgen insensitivity syndrome: a multicentre, randomised, double-dummy, double-blind crossover trial

Publication date: Available online 31 July 2018Source: The Lancet Diabetes & EndocrinologyAuthor(s): Wiebke Birnbaum, Louise Marshall, Ralf Werner, Alexandra Kulle, Paul-Martin Holterhus, Katharina Rall, Birgit Köhler, Annette Richter-Unruh, Michaela F Hartmann, Stefan A Wudy, Matthias K Auer, Anke Lux, Siegfried Kropf, Olaf HiortSummaryBackgroundWomen with complete androgen insensitivity syndrome (CAIS) after gonadectomy have complained about reduced psychological wellbeing and sexual satisfaction. The aim of this study was to compare the effectiveness of hormone-replacement therapy with either androgen or oestrogen in women with 46,XY karyotype and CAIS after gonadectomy.MethodsThis national, multicentre, double-blind, randomised crossover trial was performed at three university medical centres and three specialised treatment institutions in Germany. Eligible participants were women aged 18–54 years with 46,XY karyotype, genetically diagnosed CAIS, and removed gonads. Participants were randomly assigned (14:12) by a central computer-based minimisation method to either oestradiol 1·5 mg/day for 6 months followed by crossover to testosterone 50 mg/day for 6 months (sequence A) or to testosterone 50 mg/day for 6 months followed by crossover to oestradiol 1·5 mg/day for 6 months (sequence B). Participants also received oestradiol or testosterone dummy to avoid identification of the active substance. All participants received oestradiol 1·5 mg/day during a 2 months' run-in...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research