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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
norgestimate/ethinyl estradiol
Sponsored by
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, anorexia nervosa, pediatric

Eligibility Criteria

undefined - 17 Years (Child)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    001

    Arm Description

    norgestimate/ethinyl estradiol

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 28, 2006
    Last Updated
    June 30, 2011
    Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00320567
    Brief Title
    The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
    Official Title
    The Effect of Ortho Tri-Cyclen on Bone Mineral Density in Pediatric Subjects With Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2004 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    osteoporosis, anorexia nervosa, pediatric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    123 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    norgestimate/ethinyl estradiol
    Intervention Type
    Drug
    Intervention Name(s)
    norgestimate/ethinyl estradiol
    Primary Outcome Measure Information:
    Title
    The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
    Organizational Affiliation
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17116511
    Citation
    Strokosch GR, Friedman AJ, Wu SC, Kamin M. Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study. J Adolesc Health. 2006 Dec;39(6):819-27. doi: 10.1016/j.jadohealth.2006.09.010.
    Results Reference
    result

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

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