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Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

Primary Purpose

Endometrial Hyperplasia

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Intrauterine Device
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring Endometrial Hyperplasia without atypia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Histologic diagnosis of simple or complex endometrial hyperplasia without atypia Normal pap smear within one year Exclusion Criteria: Diabetes Family history of endometrial cancer Contraindications for the intrauterine device

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera

    Secondary Outcome Measures

    Side effects
    Bleeding profile
    Estradiol and progesterone levels

    Full Information

    First Posted
    July 20, 2005
    Last Updated
    January 7, 2013
    Sponsor
    Milton S. Hershey Medical Center
    Collaborators
    Center for Research on Women and Newborn Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00123175
    Brief Title
    Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)
    Official Title
    Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study has never received funding and has never been initiated
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    September 2011 (Anticipated)
    Study Completion Date
    September 2011 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center
    Collaborators
    Center for Research on Women and Newborn Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.
    Detailed Description
    Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Hyperplasia
    Keywords
    Endometrial Hyperplasia without atypia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Intrauterine Device
    Other Intervention Name(s)
    Medroxyprogesterone Acetate and Progestins
    Intervention Description
    Mirena and Provera
    Primary Outcome Measure Information:
    Title
    Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Side effects
    Time Frame
    90 days
    Title
    Bleeding profile
    Time Frame
    90 days
    Title
    Estradiol and progesterone levels
    Time Frame
    90 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Histologic diagnosis of simple or complex endometrial hyperplasia without atypia Normal pap smear within one year Exclusion Criteria: Diabetes Family history of endometrial cancer Contraindications for the intrauterine device
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Legro, M.D.
    Organizational Affiliation
    Penn State University College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

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