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

Sponsor
University of Helsinki (Other)
Overall Status
Completed
CT.gov ID
NCT00966264
Collaborator
University of Eastern Finland (Other), University of Oulu (Other), Tampere University (Other), University of Turku (Other)
236
2
168

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
Study Start Date :
Oct 1, 1994
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: LNG-IUS

Levonorgestrel releasing intrauterine system

Drug: LNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel
Other Names:
  • Mirena
  • Procedure: Hysterectomy
    operation
    Other Names:
  • Removal of uterus by laparoscopy, vaginally or abdominally
  • Other: Hysterectomy

    Hysterectomy

    Drug: LNG-IUS
    LNG-IUS releasing 25 microg of levonorgestrel
    Other Names:
  • Mirena
  • Procedure: Hysterectomy
    operation
    Other Names:
  • Removal of uterus by laparoscopy, vaginally or abdominally
  • Outcome Measures

    Primary Outcome Measures

    1. HRQoL (Health Related Quality of Life) [baseline and 5 years]

      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)

    2. Costs [baseline, 6 and 12 months, 5 and 10 years]

    Secondary Outcome Measures

    1. Depression [baseline, 6 and 12 months, 5 and 10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Helsinki
    • University of Eastern Finland
    • University of Oulu
    • Tampere University
    • University of Turku

    Investigators

    • Principal Investigator: Ritva S Hurskainen, MD, PhD, Helsinki University Central Hospital
    • Study Director: Jorma Paavonen, prof, University of Helsinki
    • Study Chair: Juha Teperi, prof, National Istitute For Health and Welfare, Finland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00966264
    Other Study ID Numbers:
    • Finnish Academy-project 29168
    First Posted:
    Aug 26, 2009
    Last Update Posted:
    Sep 2, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Two hundred and thirty-six women referred for essential menorrhagia to five university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n= 119) or hysterectomy (n=117).
    Pre-assignment Detail All randomised women were analysed as intention-to-treat
    Arm/Group Title LNG-IUS Hysterectomy
    Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal)
    Period Title: Overall Study
    STARTED 119 117
    COMPLETED 115 114
    NOT COMPLETED 4 3

    Baseline Characteristics

    Arm/Group Title LNG-IUS Hysterectomy Total
    Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal) Total of all reporting groups
    Overall Participants 119 117 236
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    119
    100%
    117
    100%
    236
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    43.1
    (3.5)
    43.0
    (3.2)
    43
    (3.3)
    Sex: Female, Male (Count of Participants)
    Female
    119
    100%
    117
    100%
    236
    100%
    Male
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups
    Arm/Group Title LNG-IUS Hysterectomy
    Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal)
    Measure Participants 115 114
    Mean (95% Confidence Interval) [points on a scale]
    0.08
    0.10
    2. Primary Outcome
    Title Costs
    Description
    Time Frame baseline, 6 and 12 months, 5 and 10 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    Title Depression
    Description
    Time Frame baseline, 6 and 12 months, 5 and 10 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title LNG-IUS Hysterectomy
    Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal)
    All Cause Mortality
    LNG-IUS Hysterectomy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    LNG-IUS Hysterectomy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/ (NaN) 5/ (NaN)
    Surgical and medical procedures
    bladder perforation 0/50 (0%) 0 3/109 (2.8%) 3
    peritonitis 0/50 (0%) 0 1/109 (0.9%) 1
    vesicovaginal fistula 0/50 (0%) 0 1/109 (0.9%) 1
    Other (Not Including Serious) Adverse Events
    LNG-IUS Hysterectomy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 80/ (NaN) 25/ (NaN)
    Surgical and medical procedures
    hormonal symptoms 18/119 (15.1%) 18 0/117 (0%) 0
    menstrual bleeding problems 61/119 (51.3%) 61 2/117 (1.7%) 2
    wund infection 9/50 (18%) 9 20/109 (18.3%) 20
    perioperative bleeding 1/50 (2%) 1 1/109 (0.9%) 1
    postoperative bleeding 1/50 (2%) 1 2/109 (1.8%) 2
    urinary retention 1/119 (0.8%) 1 4/117 (3.4%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Ritva Hurskainen
    Organization Helsinki University
    Phone +23845872267
    Email ritva.hurskainen@hus.fi
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00966264
    Other Study ID Numbers:
    • Finnish Academy-project 29168
    First Posted:
    Aug 26, 2009
    Last Update Posted:
    Sep 2, 2009
    Last Verified:
    Aug 1, 2009