Abstract

PurposeTo study differences in metabolic outcomes between testosterone and estradiol replacement in probands with complete androgen insensitivity syndrome (CAIS).MethodsIn this multicentre, double-blind, randomized crossover trial, 26 women with CAIS were included of whom 17 completed the study. After a two-months run in phase with estradiol, probands either received transdermal estradiol followed by crossover to transdermal testosterone or vice versa. After six months, differences in lipids, fasting glucose, insulin, hematocrit, liver parameters and blood pressure between the treatment phases were investigated.ResultsLinear mixed models adjusted for period and sequence did not reveal major group differences according to treatment for the investigated outcomes. In each treatment group, there were however significant uniform changes in BMI and cholesterol. BMI increased significantly, following six months of estradiol ( + 2.7%; p = 0.036) as well as testosterone treatment ( + 2.8%; p = 0.036). There was also a significant increase in total ( + 10.4%; p = 0.001) and LDL-cholesterol ( + 29.2%; p = 0.049) and a decrease in HDL-cholesterol (−15.8%; p < 0.001) following six months of estradiol as well as six months of testosterone treatment (total cholesterol: + 14.6%; p = 0.008; LDL-cholesterol: + 39.1%; p = 0.005, HDL-cholesterol: −15.8%; p = 0.004). Other parameters remained unchanged.ConclusionTransdermal estradiol as well as testosterone treatment in women with CAIS results in worsening in lipid profiles. Given the relatively small sample size, subtle group differences in other metabolic parameters may have remained undetected.

Highlights

  • Complete androgen insensitivity syndrome (CAIS) is the most common 46, XY disorder of sex development (DSD) with an estimated prevalence of 1 in 20. 000–90. 000 births or 4·1:100 000 girls [1]

  • The concentrations of Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) hormone were high before treatment (After run-in: LH 33.9IU/l; FSH 55.7IU/l) and remained high after treatment

  • In summary we could show both treatments seem to result in a worsened lipid profile while we did not detect major changes or group differences in other parameters

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Summary

Introduction

Complete androgen insensitivity syndrome (CAIS) is the most common 46, XY disorder of sex development (DSD) with an estimated prevalence of 1 in 20. 000–90. 000 births or 4·1:100 000 girls [1]. 000 births or 4·1:100 000 girls [1] It is characterized by complete loss of androgen receptor functioning due to X-linked recessive mutations within the androgen receptor (AR) gene [2] and subsequent development of a complete external female phenotype. Due to the unknown risk for developing gonadal tumors, women with CAIS usually underwent early gonadectomy until recently [2] and were depended on sex hormone replacement therapy. The treatment of patients with CAIS after gonadectomy has basically followed the established concepts for the therapy of female hypogonadism. This results in the replacement of previously high endogenous androgen concentrations by estrogens [2]

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