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

McNeil-PPC

Status and phase

Completed

Phase 2

Conditions

Osteoporosis

Treatments

Drug: norgestimate/ethinyl estradiol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00320567

CR008332

Details and patient eligibility

About

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.

Full 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 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

Enrollment

123 patients

Sex

Female

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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.