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Trial record 86 of 404 for:    LEVONORGESTREL

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
Layout table for Results Point of Contact information
Name/Title: Ritva Hurskainen
Organization: Helsinki University
Phone: +23845872267
EMail: ritva.hurskainen@hus.fi
Layout table for additonal information
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