Status:
TERMINATED
Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Novo Nordisk A/S
University of Michigan
Conditions:
Turner's Syndrome
Eligibility:
FEMALE
138-13 years
Phase:
PHASE1
Brief Summary
This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner s...
Detailed Description
Determining the estrogen replacement regimen which is optimal with GH therapy is an important issue in the management of Turner syndrome today. The estrogen effect on growth is biphasic, stimulatory a...
Eligibility Criteria
Inclusion
- 60 subjects will be recruited from participating Pediatric Endocrinology Clinics in the United States.
- Subjects will be 11.5-13.0 years of age and must have completed at least 6 months of GH therapy prior to the study.
- Subjects may not have had any estrogen prior to the study. All subjects must be breast stage 1 and euthyroid prior to the study
- Those on thyroid medication will continue the appropriate thyroid replacement therapy during the study.
Exclusion
- On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00870220
Start Date
April 1 2009
End Date
March 1 2011
Last Update
March 11 2014
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
John Hopkins University
Baltimore, Maryland, United States, 21287
3
University of Michigan
Ann Arbor, Michigan, United States, 48109