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

June 30, 2011 updated by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

The Effect of Ortho Tri-Cyclen on Bone Mineral Density in Pediatric Subjects With Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 001
norgestimate/ethinyl estradiol
Drug: norgestimate/ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

April 1, 2004

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR008332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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