The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
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|ClinicalTrials.gov Identifier: NCT00320567|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: norgestimate/ethinyl estradiol||Phase 2|
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 norgestimate/ethinyl estradiol or placebo for 13 consecutive 28-day cycles. Norgestimate/Ethinyl Estradiol is packaged in a 28-day blistercard. Each tablet contains the following:
a) Days 1-7 0.180 mg norgestimate/0.035 mg ethinyl estradiol b) Days 8-14 0.215 mg norgestimate/0.035 mg ethinyl estradiol c) Days 15-21 0.250 mg norgestimate/0.035 mg ethinyl estradiol d) Days 22-28 inactive tablets;One 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Ortho Tri-Cyclen on Bone Mineral Density in Pediatric Subjects With Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study|
|Study Completion Date :||April 2004|
|Drug: norgestimate/ethinyl estradiol|
- The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).
- The percent change in total lumbar spine BMD from baseline to Cycle 6. The change and percent change in total lumbar spine BMD from baseline to Cycle 13. The change and percent change in total hip BMD from baseline to Cycle 6 and Cycle 13.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320567
|Study Director:||McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial||McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.|