Comparison of clinical and metabolic effects of testosterone and estradiol in adult gonadectomized patients with normal male chromosome set and Disorder of Sex Developement due to complete androgen insensitivity syndrome (CAIS)

Phase 1

Conditions: The medical condition under investigation is complete androgen insensitivity syndrome (CAIS) in gonadectomized patients with 46,XY karyotype due to mutations of the androgen receptor, which lead to loss of function of androgens.
MedDRA version: 14.1Level: PTClassification code 10056292Term: Androgen insensitivity syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2010-021790-37-DE

Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Lübeck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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
Porphyria
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