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Completed

NCT Number: NCT00966264

Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

35 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LNG-IUS

Drug

LNG-IUS releasing 25 microg of levonorgestrel

Other names: Mirena

Hysterectomy

Procedure

operation

Other names: Removal of uterus by laparoscopy, vaginally or abdominally

Primary outcomes

  1. 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)

  2. Costs

    Time frame: baseline, 6 and 12 months, 5 and 10 years

Secondary outcomes

  1. Depression

    Time frame: baseline, 6 and 12 months, 5 and 10 years

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

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

Registry information

Official study title

Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

Acronym: VUOKKO

Important dates

Study start
1994
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2009
Registry last updated
Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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