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

Overview

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.

Full Title of Study: “Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2008

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).

Interventions

  • Drug: LNG-IUS
    • LNG-IUS releasing 25 microg of levonorgestrel
  • Procedure: Hysterectomy
    • operation

Arms, Groups and Cohorts

  • Active Comparator: LNG-IUS
    • Levonorgestrel releasing intrauterine system
  • Other: Hysterectomy
    • Hysterectomy

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • Costs
    • Time Frame: baseline, 6 and 12 months, 5 and 10 years

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 35 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Helsinki
  • Collaborator
    • University of Eastern Finland
  • Provider of Information About this Clinical Study
    • Ritva Hurskainen, project manager, Helsinki University Hospital
  • Overall Official(s)
    • Ritva S Hurskainen, MD, PhD, Principal Investigator, Helsinki University Central Hospital
    • Jorma Paavonen, prof, Study Director, University of Helsinki
    • Juha Teperi, prof, Study Chair, National Istitute For Health and Welfare, Finland

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