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

This study has been completed.
Sponsor:
Collaborators:
University of Eastern Finland
University of Oulu
University of Tampere
University of Turku
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00966264
First received: January 20, 2009
Last updated: August 26, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Menorrhagia
Drug: LNG-IUS
Procedure: Hysterectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • HRQoL (Health Related Quality of Life) [ Time Frame: baseline and 5 years ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: October 1994
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   35 Years to 49 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
Study Director: Jorma Paavonen, prof Helsinki University
Study Chair: Juha Teperi, prof National Istitute For Health and Welfare, Finland
  More Information

No publications provided

Responsible Party: Ritva Hurskainen, project manager, Helsinki University Hospital
ClinicalTrials.gov Identifier: NCT00966264     History of Changes
Other Study ID Numbers: Finnish Academy-project 29168
Study First Received: January 20, 2009
Results First Received: January 20, 2009
Last Updated: August 26, 2009
Health Authority: Finland: Ministry of Social Affairs and Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014