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

August 26, 2009 updated by: University of Helsinki

Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

236

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LNG-IUS
Levonorgestrel releasing intrauterine system
Drug: LNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel
Other Names:
  • Mirena
Procedure: Hysterectomy
operation
Other Names:
  • Removal of uterus by laparoscopy, vaginally or abdominally
OTHER: Hysterectomy
Drug: LNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel
Other Names:
  • Mirena
Procedure: Hysterectomy
operation
Other Names:
  • Removal of uterus by laparoscopy, vaginally or abdominally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQoL (Health Related Quality of Life)
Time Frame: baseline and 5 years
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
Time Frame: baseline, 6 and 12 months, 5 and 10 years
baseline, 6 and 12 months, 5 and 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression
Time Frame: baseline, 6 and 12 months, 5 and 10 years
baseline, 6 and 12 months, 5 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

University of Turku
Tampere University
University of Eastern Finland
University of Oulu

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1994

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (ESTIMATE)

August 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2009

Last Update Submitted That Met QC Criteria

August 26, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Finnish Academy-project 29168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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