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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Menorrhagia Drug: LNG-IUS Procedure: Hysterectomy Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
Study Start Date : October 1994
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: LNG-IUS
Levonorgestrel releasing intrauterine system
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
Hysterectomy
Hysterectomy
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


Outcome Measures

Primary Outcome Measures :
  1. HRQoL (Health Related Quality of Life) [ Time Frame: baseline and 5 years ]
  2. Costs [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ]

Secondary Outcome Measures :
  1. Depression [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966264


Sponsors and Collaborators
Helsinki University
University of Eastern Finland
University of Oulu
University of Tampere
University of Turku
Investigators
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
More 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 Posted: August 26, 2009    Key Record Dates
Results First Posted: August 26, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009

Keywords provided by Helsinki University:
randomized controlled trial
menorrhagia
LNG-IUS
hysterectomy

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral