Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
VUOKKO
1 other identifier
interventional
236
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 1994
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedResults Posted
Study results publicly available
August 26, 2009
CompletedSeptember 2, 2009
August 1, 2009
14 years
January 20, 2009
January 20, 2009
August 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
baseline and 5 years
Costs
baseline, 6 and 12 months, 5 and 10 years
Secondary Outcomes (1)
Depression
baseline, 6 and 12 months, 5 and 10 years
Study Arms (2)
LNG-IUS
ACTIVE COMPARATORLevonorgestrel releasing intrauterine system
Hysterectomy
OTHERHysterectomy
Interventions
operation
Eligibility Criteria
You may qualify if:
- heavy menstrual bleeding
- years
- were menstruating
- had completed their family size
- were eligible for both treatments
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Helsinkilead
- University of Eastern Finlandcollaborator
- University of Oulucollaborator
- Tampere Universitycollaborator
- University of Turkucollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ritva Hurskainen
- Organization
- Helsinki University
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2009
First Posted
August 26, 2009
Study Start
October 1, 1994
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
September 2, 2009
Results First Posted
August 26, 2009
Record last verified: 2009-08