Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320567
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2006-04-28
Brief Title:
The Effect of NorgestimateEthinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
The Effect of Ortho Tri-Cyclen on Bone Mineral Density in Pediatric Subjects With Anorexia Nervosa A Double-Blind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of norgestimateethinyl estradiol on lumbar spine L1-L4 and total hip bone mineral density BMD in pediatric subjects with anorexia nervosa
Detailed Description:
Although oral contraceptives are prescribed in an effort to prevent bone loss in adolescents with anorexia nervosa there have been no previous definitive placebo-controlled studies evaluating the effectiveness of oral contraceptive treatment on bone mineral density in pediatric females with anorexia nervosa This is a randomized patients are assigned different treatments based on chance multicenter double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage placebo-controlled study to evaluate the bone mineral density in pediatric patients with anorexia nervosa following treatment with norgestimateethinyl estradiol or placebo for 13 consecutive 28-day cycles NorgestimateEthinyl Estradiol is packaged in a 28-day blistercard Each tablet contains the following
a Days 1-7 0180 mg norgestimate0035 mg ethinyl estradiol b Days 8-14 0215 mg norgestimate0035 mg ethinyl estradiol c Days 15-21 0250 mg norgestimate0035 mg ethinyl estradiol d Days 22-28 inactive tabletsOne tablet is to be taken once daily by mouth After 28 days the next cycle is started the following day without interruption Color-matched placebo tablets are identically pack
a Days 1-7 0180 mg norgestimate0035 mg ethinyl estradiol b Days 8-14 0215 mg norgestimate0035 mg ethinyl estradiol c Days 15-21 0250 mg norgestimate0035 mg ethinyl estradiol d Days 22-28 inactive tabletsOne tablet is to be taken once daily by mouth After 28 days the next cycle is started the following day without interruption Color-matched placebo tablets are identically pack
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None