The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa

NCT00320567 | Completed Phase 2

• 1 other identifier: CR008332
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa.

Conditions

Osteoporosis

Keywords

osteoporosis; anorexia nervosa; pediatric

Outcome Measures

Primary Outcomes (1)

• The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).

Secondary Outcomes (1)

• 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.

Study Arms (1)

001

EXPERIMENTAL

norgestimate/ethinyl estradiol

Drug: norgestimate/ethinyl estradiol

Interventions

norgestimate/ethinyl estradiol DRUG

001

Eligibility Criteria

• Age: Up to 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients must have a monthly period
• health status consistent with anorexia nervosa
• meet the modified DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) guideline for anorexia nervosa
• must discontinue the following prior to Baseline visit: hormonal contraceptives for 3 months
• hormonal intrauterine devices (IUDs) for 1 month
• NORPLANT for 3 months
• DepoProvera and other depot hormone injections, for 6 months
• Lupron, Lupron Depot 3.75 mg and 7.5 mg, Synarel, Zoladex, Cetrotide for 3 months
• Lupron Depot 11.25 mg, 15 mg, 22.5 mg, 30 mg for 6 months
• non-smoker or smoking \<= 15 cigarettes per day
• must agree to use reliable non-hormonal alternate method of birth control during the study

You may not qualify if:

• History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products, known or suspected carcinoma of any body system, diabetes mellitus with vascular involvement
• recent history of alcohol or substance abuse
• patients with primary amenorrhea (abnormal suppression or absence of menstruation) who in the opinion of the physician, are not appropriate candidates for hormonal therapy (eg, have not grown to an acceptable adult height)
• subjects who are suicidal
• patients who have received any experimental drug and/or used any experimental device within 30 days before the start of the study.

Sponsors & Collaborators

• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: lead

Related Publications (1)

• Strokosch GR, Friedman AJ, Wu SC, Kamin M. Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study. J Adolesc Health. 2006 Dec;39(6):819-27. doi: 10.1016/j.jadohealth.2006.09.010.

  PMID: 17116511 RESULT

MeSH Terms

Conditions

Osteoporosis; Anorexia Nervosa

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

  McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Completion: April 1, 2004
• Last Updated: July 1, 2011

Record last verified: 2011-06