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Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

Primary Purpose

Osteopenia

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Seasonale (levonorgestrel and ethinyl estradiol)
Sponsored by
Duramed Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring osteopenia, bone mineral density, amenorrhea, adolescents

Eligibility Criteria

12 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Not sexually active and agree to remain sexually inactive throughout the course of the study First menstrual period at least one year ago No menstrual period in the last 6 months Exclusion Criteria: Undiagnosed abnormal genital bleeding Known or suspected pregnancy Medical history of any disorder that contraindicates the use of oral contraceptives

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mean percent change in the lumbar spine bone mineral density at month 12

    Secondary Outcome Measures

    Interim and 24 month mean percent change in lumbar spine bone mineral density
    Mean percent change in the proximal femur (hip) bone mineral density
    Mean percent change in total body bone mineral density
    Mean change in biochemical markers of bone resorption and bone formation
    Change in body weight

    Full Information

    First Posted
    June 30, 2005
    Last Updated
    August 8, 2013
    Sponsor
    Duramed Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00117260
    Brief Title
    Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Duramed Research

    4. Oversight

    5. Study Description

    Brief Summary
    This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteopenia
    Keywords
    osteopenia, bone mineral density, amenorrhea, adolescents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Seasonale (levonorgestrel and ethinyl estradiol)
    Primary Outcome Measure Information:
    Title
    Mean percent change in the lumbar spine bone mineral density at month 12
    Secondary Outcome Measure Information:
    Title
    Interim and 24 month mean percent change in lumbar spine bone mineral density
    Title
    Mean percent change in the proximal femur (hip) bone mineral density
    Title
    Mean percent change in total body bone mineral density
    Title
    Mean change in biochemical markers of bone resorption and bone formation
    Title
    Change in body weight

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Not sexually active and agree to remain sexually inactive throughout the course of the study First menstrual period at least one year ago No menstrual period in the last 6 months Exclusion Criteria: Undiagnosed abnormal genital bleeding Known or suspected pregnancy Medical history of any disorder that contraindicates the use of oral contraceptives

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

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