A placebo controlled study on the effect of oxandrolone, growth hormone and low-dose estrogens on growth, psychological parameters, and characteristics of the voicein girls with Turner's syndrome.
Completed
- Conditions
- Girls with Turner syndrome.
- Registration Number
- NL-OMON29682
- Lead Sponsor
- ederlandse Groeistichting (Dutch Growth Foundation)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 133
Inclusion Criteria
1. The diagnosis Turner syndrome should be confirmed by lymphocyte chromosomal analysis;
2. Chronological age between 2 and 15.99 years;
Exclusion Criteria
1. Any endocrine or metabolic disorder, such as diabetes mellitus, diabetes insipidus or inborn errors of metabolism, with the exeption of thyroidal illnesses adequately treated/substituted;
2. Growth failure due to disorders of urinary, cardiopulmonary, gastro-intestinal and nervous system; nutritional/vitamin deficiencies and chondrodysplasias;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effects of the various treatment regimens will be analysed in terms of:<br /> <br>1. Clinical, auxological and biochemical parameters;<br /><br>2. (Changes in) characteristics of the voice;<br /> <br>3. Psychological parameters.
- Secondary Outcome Measures
Name Time Method To assess the effects of oxandrolone on: <br /><br>1. Carbohydrate metabolism;<br /><br>2. Abnormalities of liver function;<br /><br>3. Thyroxine binding globulin levels;<br /><br>4. Masculinizing effects.