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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

Conditions
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Menorrhagia

Intervention / Treatment
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* Drug: LNG-IUS
* Procedure: Hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LNG-IUS<br>Levonorgestrel releasing intrauterine system | Drug: LNG-IUS<br>* LNG-IUS releasing 25 microg of levonorgestrel<br>* Other names: Mirena;Procedure: Hysterectomy<br>* operation<br>* Other names: Removal of uterus by laparoscopy, vaginally or abdominally;|
| Other: Hysterectomy<br>Hysterectomy | Drug: LNG-IUS<br>* LNG-IUS releasing 25 microg of levonorgestrel<br>* Other names: Mirena;Procedure: Hysterectomy<br>* operation<br>* Other names: Removal of uterus by laparoscopy, vaginally or abdominally;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | baseline, 6 and 12 months, 5 and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy