Status:
COMPLETED
Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Turner Syndrome
Hypogonadism
Eligibility:
FEMALE
13-20 years
Phase:
PHASE4
Brief Summary
Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pe...
Detailed Description
Data on the specific effects and bioequivalency of the different forms of estrogen are lacking, and in the young adolescent age group in particular, virtually non-existent. This has been complicated f...
Eligibility Criteria
Inclusion
- Girls with Turner Syndrome (45X, or related karyotypes) diagnosed clinically and cytogenetically
- Female subjects with Y material will be allowed providing gonadectomies have been performed previously
- Age: 13-20 years
- Subjects have completed or nearly completed their linear growth
- Previous growth hormone (GH) therapy discontinued at least 6 months prior to study participation
- Stable thyroid replacement therapy will be allowed
- Celiac disease on stable diets will be allowed
- Any previous hormone replacement therapy (HRT) will be allowed
Exclusion
- Diabetes Mellitus on insulin therapy, insulin sensitizers or oral hypoglycemics
- Inflammatory Bowel Disease (ulcerative colitis or Crohn's disease), celiac disease
- Cigarette smoking
- Any other chronic conditions, that, in the opinion of investigators could impair the metabolism of nutrients
- Severe obesity, i.e., Body Mass Index (BMI) \>95th centile
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00837616
Start Date
January 1 2009
End Date
December 1 2012
Last Update
May 16 2023
Active Locations (3)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
2
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
3
University of Chile/Clinica las Condes
Santiago, Chile