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

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norgestimate; Norgestrel; Polyestradiol phosphate

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.