Status:
COMPLETED
Somatropin Treatment to Final Height in Turner Syndrome
Lead Sponsor:
Eli Lilly and Company
Conditions:
Turner Syndrome
Eligibility:
FEMALE
7-13 years
Phase:
PHASE3
Brief Summary
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promot...
Detailed Description
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry. Core study objectives are to determine the ef...
Eligibility Criteria
Inclusion
- girl with Turner syndrome
- prepubertal, Tanner stage I breast
- height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population
- at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity
- if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests
Exclusion
- prior treatment with growth hormone
- presence of a Y component in karyotype with gonads in situ
- diabetes mellitus
Key Trial Info
Start Date :
February 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00191113
Start Date
February 1 1989
End Date
December 1 2007
Last Update
January 27 2010
Active Locations (14)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calgary, Alberta, Canada, T2T 5C7
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edmonton, Alberta, Canada, T6G 2B7
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver, British Columbia, Canada, V6H 3V4
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winnipeg, Manitoba, Canada, R3E 0Z2