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: 14.1 Level: PT Classification code 10056292 Term: Androgen insensitivity syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Gynokadin® Dosiergel
Pharmaceutical Form: Gel
CAS Number: 50-28-2
Other descriptive name: ESTRADIOL HEMIHYDRATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concen
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postpubertal adult patients (age >= 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Detection of differences in the effects of testosterone versus estradiol treatment on general quality of life measured by psychological sum scale of the SF-36 questionnaire;Secondary Objective: Comparison of levels and excretion products of testosterone, estradiol and other metabolites of sexual hormones Analysis of effects of different levels of hormones on the levels of SHBG, LH, FSH, Insulin, Glucose, Cholesterol (total, HDL, LDL), Triglycerides, Hematocrit and Hemoglobin Detection of differences in the effects of testosterone versus estradiol treatment on general and sexual quality of life Analysis of residual androgen receptor activity and correlation between residual activity and effects of testosteron Comparison of the incidence of adverse events between both treatments ;Primary end point(s): Quality of life as measured by the psychlogical sum scale of the SF-36 questionnaire;Timepoint(s) of evaluation of this end point: At months 0, 2 (start of study medication 1), 5, 8 (end of study medication 1 and start of study medication 2), 11, 14 (end of study medikation 2) and 17 (end of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life as measured by the physical sum scale of the SF-36 questionnaire Psychological well-being assessed by the questionnaire Brief Symptom Inventory Sexual quality of life as measured by the questionnaire FSFI-d Hormone levels in serum and urine, SHBG, LH, FSH, Insulin, Glucose, Cholesterol (total, HDL, LDL), Triglycerides, Hematocrit and Hemoglobin Adverse events ;Timepoint(s) of evaluation of this end point: At months 0, 2 (start of study medication 1), 5, 8 (end of study medication 1 and start of study medication 2), 11, 14 (end of study medikation 2) and 17 (end of study). | — |
Countries
Germany
Contacts
Public ContactStudy coordination
Universitätsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin
Outcome results
None listed