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Trial record 86 of 403 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

Tracking Information
First Submitted Date  ICMJE January 20, 2009
First Posted Date  ICMJE August 26, 2009
Results First Submitted Date  ICMJE January 20, 2009
Results First Posted Date  ICMJE August 26, 2009
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE October 1994
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
  • HRQoL (Health Related Quality of Life) [ Time Frame: baseline and 5 years ]
  • Costs [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00966264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
Depression [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Official Title  ICMJE Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menorrhagia
Intervention  ICMJE
  • Drug: LNG-IUS
    LNG-IUS releasing 25 microg of levonorgestrel
    Other Name: Mirena
  • Procedure: Hysterectomy
    operation
    Other Name: Removal of uterus by laparoscopy, vaginally or abdominally
Study Arms  ICMJE
  • Active Comparator: LNG-IUS
    Levonorgestrel releasing intrauterine system
    Interventions:
    • Drug: LNG-IUS
    • Procedure: Hysterectomy
  • Hysterectomy
    Hysterectomy
    Interventions:
    • Drug: LNG-IUS
    • Procedure: Hysterectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2009)
236
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00966264
Other Study ID Numbers  ICMJE Finnish Academy-project 29168
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ritva Hurskainen, project manager, Helsinki University Hospital
Study Sponsor  ICMJE Helsinki University
Collaborators  ICMJE
  • University of Eastern Finland
  • University of Oulu
  • Tampere University
  • University of Turku
Investigators  ICMJE
Principal Investigator: Ritva S Hurskainen, MD, PhD Helsinki University Central Hospital
Study Director: Jorma Paavonen, prof Helsinki University
Study Chair: Juha Teperi, prof National Istitute For Health and Welfare, Finland
PRS Account Helsinki University
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP