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
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy
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
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
NCT ID
NCT00966264
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
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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