The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
Osteoporosis
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, anorexia nervosa, pediatric
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Experimental
001
norgestimate/ethinyl estradiol