Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004275
Status:
COMPLETED
Last Update Posted:
2008-09-10
First Post:
1999-10-18
Brief Title:
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turners Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turners Syndrome
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Turners syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen Giving growth hormone may help girls with Turners syndrome attain a more normal height It is not yet known if growth hormone is more effective with or without oxandrolone for Turners syndrome
PURPOSE Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turners syndrome
PURPOSE Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turners syndrome
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are randomly assigned to recombinant human growth hormone GH and oxandrolone versus GH and placebo
GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth Treatment continues for 3 years estrogen is offered after year 2
A study duration of 8 years is anticipated
GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth Treatment continues for 3 years estrogen is offered after year 2
A study duration of 8 years is anticipated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TJU-11681 | None | None | None |