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

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ClinicalTrials.gov Identifier: NCT00966264
Recruitment Status : Completed
First Posted : August 26, 2009
Results First Posted : August 26, 2009
Last Update Posted : September 2, 2009
Sponsor:
Collaborators:
University of Eastern Finland
University of Oulu
Tampere University
University of Turku
Information provided by:
Helsinki University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Menorrhagia
Interventions Drug: LNG-IUS
Procedure: Hysterectomy
Enrollment 236
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 Details All randomised women were analysed as intention-to-treat
Arm/Group Title LNG-IUS Hysterectomy
Hide Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal)
Period Title: Overall Study
Started 119 117
Completed 115 [1] 114 [1]
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             4             3
[1]
5 years results
Arm/Group Title LNG-IUS Hysterectomy Total
Hide Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal) Total of all reporting groups
Overall Number of Baseline Participants 119 117 236
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 117 participants 236 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
119
 100.0%
117
 100.0%
236
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 117 participants 236 participants
43.1  (3.5) 43.0  (3.2) 43  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 117 participants 236 participants
Female
119
 100.0%
117
 100.0%
236
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title HRQoL (Health Related Quality of Life)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Levonorgestrel releasing intrauterine system (LNG-IUS)
Hysterectomy (abdominal,laparoscopical or vaginal)
Overall Number of Participants Analyzed 115 114
Mean (95% Confidence Interval)
Unit of Measure: points on a scale
0.08
(0.03 to 0.13)
0.10
(0.05 to 0.15)
2.Primary Outcome
Title Costs
Hide Description [Not Specified]
Time Frame baseline, 6 and 12 months, 5 and 10 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Depression
Hide Description [Not Specified]
Time Frame baseline, 6 and 12 months, 5 and 10 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LNG-IUS Hysterectomy
Hide Arm/Group Description Levonorgestrel releasing intrauterine system (LNG-IUS) Hysterectomy (abdominal,laparoscopical or vaginal)
All-Cause Mortality
LNG-IUS Hysterectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LNG-IUS Hysterectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      5    
Surgical and medical procedures     
bladder perforation   0/50 (0.00%)  0 3/109 (2.75%)  3
peritonitis   0/50 (0.00%)  0 1/109 (0.92%)  1
vesicovaginal fistula   0/50 (0.00%)  0 1/109 (0.92%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 20%
LNG-IUS Hysterectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80      25    
Surgical and medical procedures     
hormonal symptoms   18/119 (15.13%)  18 0/117 (0.00%)  0
menstrual bleeding problems   61/119 (51.26%)  61 2/117 (1.71%)  2
wund infection   9/50 (18.00%)  9 20/109 (18.35%)  20
perioperative bleeding   1/50 (2.00%)  1 1/109 (0.92%)  1
postoperative bleeding   1/50 (2.00%)  1 2/109 (1.83%)  2
urinary retention   1/119 (0.84%)  1 4/117 (3.42%)  4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ritva Hurskainen
Organization: Helsinki University
Phone: +23845872267
Responsible Party: Ritva Hurskainen, project manager, Helsinki University Hospital
ClinicalTrials.gov Identifier: NCT00966264     History of Changes
Other Study ID Numbers: Finnish Academy-project 29168
First Submitted: January 20, 2009
First Posted: August 26, 2009
Results First Submitted: January 20, 2009
Results First Posted: August 26, 2009
Last Update Posted: September 2, 2009