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

Phase 3

• Conditions: E34.5; Androgen resistance syndrome

• Registration Number: DRKS00003136
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Lübeck, kaufmännischer Vorstand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-11
• Study Completion: 2016-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Postpubertal adult patient with complete androgen insensitivity syndrome classified as either Sinnecker Type 5A or 5B (1)
Mutation of the androgen receptor gene proved
Gonadectomy at least 1 year before entering the study

Exclusion Criteria

1. Disorder of Sex Development other than complete androgen insensitivity syndrome
2. Steroid medication other than study trial medication
3. Gonads in situ
4. Disorder of liver function
5. Chronic skin disease
6. Serious chronic disorders affected by sex steroid medication
7. Malignant disorders
8. Severe psychiatric disorders
9. Porphyria
10. previous venous thromboembolism or arterial embolism
11. hypersensitivity versus active substance or auxiliary substances of study medication
12. participation in other clinical trial in the foregone 4 weeks, individual decision of the principal investigator possible
13. any circumstances that arise doubts that the trial is reasonable for the individual patient or circumstances that hinder a protocol conform conduct

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective: To detect differences in the effects of testosterone versus estrogen treatment on quality of life and mental health/psychological well being in patients with complete androgen insensitivity at seven visit dates (after 0, 2, 5, 8, 11, 14, 17 treatment months). <br>measuring instrument: psychological sum scale of the SF-36-questionnaire (= Short Form Health Survey)

Secondary Outcome Measures

Name	Time	Method
Secondary objectives: To compare the levels of testosterone and estradiol, as well as other sex steroid metabolites between both treatments and to determine steroid extraction profiles and levels of SHBG, Insulin, Cholesterol (total, HDL, LDL), Triglycerides, Hematocrit, Haemoglobin in serum or EDTA-blood respectively, as control parameters and to investigate the correlations with quality of life and hormones (measured through questionnaires: physical Sumscale SF-36= = Short Form Health Survey, FSFI-d =Female Sexual Function Index, BSI = Body Symptom Inventory).<br>Furthermore we will include functional analysis of the androgen receptor regarding residual activity in correlation to hormone levels.<br>Rate of side effects will be measured in both treatment arms.