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Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia (VUOKKO)

Primary Purpose

Menorrhagia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
LNG-IUS
Hysterectomy
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy

Eligibility Criteria

35 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • heavy menstrual bleeding
  • 35-49 years
  • were menstruating
  • had completed their family size
  • were eligible for both treatments

Exclusion Criteria:

  • submucous fibroids
  • endometrial polyps
  • ovarian tumours or cysts,
  • cervical pathology
  • urinary and bowel symptoms or pain due to large fibroids
  • lack of indication for hysterectomy
  • history of malignancies
  • menopause
  • severe depression
  • metrorrhagia as a main complaint
  • previous treatment failure with LNG-IUS
  • severe acne
  • uterine malformation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    LNG-IUS

    Hysterectomy

    Arm Description

    Levonorgestrel releasing intrauterine system

    Hysterectomy

    Outcomes

    Primary Outcome Measures

    HRQoL (Health Related Quality of Life)
    HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)
    Costs

    Secondary Outcome Measures

    Depression

    Full Information

    First Posted
    January 20, 2009
    Last Updated
    August 26, 2009
    Sponsor
    University of Helsinki
    Collaborators
    University of Eastern Finland, University of Oulu, Tampere University, University of Turku
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00966264
    Brief Title
    Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
    Acronym
    VUOKKO
    Official Title
    Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1994 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Helsinki
    Collaborators
    University of Eastern Finland, University of Oulu, Tampere University, University of Turku

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs.
    Detailed Description
    A randomized VUOKKO trial was conducted between 1994-2008 to study hysterectomy and LNG-IUS in the treatment of menorrhagia.Overall, 236 women aged 35 to 49 years who were menstruating, had completed their family size, and were eligible for both treatments were randomized to either receive a LNG-IUS (n=119) or undergo hysterectomy (n=117). The follow-up visits took place six months and 12 months after the treatment, and again five and ten years after the randomization. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs. The amount of menstrual blood loss was objectively measured before treatment and after one and five years. The one year the results were published in 2001 (Lancet 2001;357:273) and the five year results in 2004 (JAMA 2004; 291:1456).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menorrhagia
    Keywords
    randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    236 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LNG-IUS
    Arm Type
    Active Comparator
    Arm Description
    Levonorgestrel releasing intrauterine system
    Arm Title
    Hysterectomy
    Arm Type
    Other
    Arm Description
    Hysterectomy
    Intervention Type
    Drug
    Intervention Name(s)
    LNG-IUS
    Other Intervention Name(s)
    Mirena
    Intervention Description
    LNG-IUS releasing 25 microg of levonorgestrel
    Intervention Type
    Procedure
    Intervention Name(s)
    Hysterectomy
    Other Intervention Name(s)
    Removal of uterus by laparoscopy, vaginally or abdominally
    Intervention Description
    operation
    Primary Outcome Measure Information:
    Title
    HRQoL (Health Related Quality of Life)
    Description
    HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)
    Time Frame
    baseline and 5 years
    Title
    Costs
    Time Frame
    baseline, 6 and 12 months, 5 and 10 years
    Secondary Outcome Measure Information:
    Title
    Depression
    Time Frame
    baseline, 6 and 12 months, 5 and 10 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: heavy menstrual bleeding 35-49 years were menstruating had completed their family size were eligible for both treatments Exclusion Criteria: submucous fibroids endometrial polyps ovarian tumours or cysts, cervical pathology urinary and bowel symptoms or pain due to large fibroids lack of indication for hysterectomy history of malignancies menopause severe depression metrorrhagia as a main complaint previous treatment failure with LNG-IUS severe acne uterine malformation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ritva S Hurskainen, MD, PhD
    Organizational Affiliation
    Helsinki University Central Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jorma Paavonen, prof
    Organizational Affiliation
    University of Helsinki
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Juha Teperi, prof
    Organizational Affiliation
    National Istitute For Health and Welfare, Finland
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia

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