Comparison of clinical and metabolic effects of testosterone and estradiol in adult gonadectomized patients with 46,XY DSD due to complete androgen insensitivity syndrome (CAIS) - CAIS

niversitätsklinikum Schleswig-Holstein, Campus Lübeck0 个研究点目标入组 30 人开始时间: 2011年8月10日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•Postpubertal adult patients (age >= 18 and <= 55 years) with complete androgen insensitivity syndrome with 46, XY karyotype classified as either Sinnecker Type 5A or 5B
•Mutation of the androgen receptor gene proved
•Gonadectomy at least 1 year before entering the study
•Informed consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Disorder of sex developement other than complete androgen insensitivity syndrome
•Steroid medication other than study medication (exception: steroids for inhalation, short-term administration of other steroids)
•Gonads in situ
•Disorder of liver function
•Chronic skin disease with influence on resorption of the gels
•Serious chronic disorders affected by sex steroid medication
•Malignant disorders (exception: cured malignant disorders which are not dependent on hormones)
•Severe psychiatric disorder
•Previous idiopathic or present venous thrombotic or embolic events
•Present or recent arterial thrombotic or embolic events (e.g. myocardial infarction or angina pectoris)
•Allergy to study medication or excipients in study medication
•Clinical trial therapy outside of this trial during or within 4 weeks of study treatment

发起方

niversitätsklinikum Schleswig-Holstein, Campus Lübeck