Status:
COMPLETED
The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Osteoporosis
Eligibility:
FEMALE
Up to 17 years
Phase:
PHASE2
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.
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 eff...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00320567
End Date
April 1 2004
Last Update
July 1 2011
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