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| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
| University of Oulu | OTHER |
| Tampere University | OTHER |
| University of Turku |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNG-IUS | Active Comparator | Levonorgestrel releasing intrauterine system |
|
| Hysterectomy | Other | Hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNG-IUS | Drug | LNG-IUS releasing 25 microg of levonorgestrel |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | baseline, 6 and 12 months, 5 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ritva S Hurskainen, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Jorma Paavonen, prof | University of Helsinki | Study Director |
| Juha Teperi, prof | National Istitute For Health and Welfare, Finland | Study Chair |
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All randomised women were analysed as intention-to-treat
Two hundred and thirty-six women referred for essential menorrhagia to five university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n= 119) or hysterectomy (n=117).
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| ID | Title | Description |
|---|---|---|
| FG000 | LNG-IUS | Levonorgestrel releasing intrauterine system (LNG-IUS) |
| FG001 | Hysterectomy | Hysterectomy (abdominal,laparoscopical or vaginal) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LNG-IUS | Levonorgestrel releasing intrauterine system (LNG-IUS) |
| BG001 | Hysterectomy | Hysterectomy (abdominal,laparoscopical or vaginal) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups | Posted | Mean | 95% Confidence Interval | points on a scale | baseline and 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LNG-IUS | Levonorgestrel releasing intrauterine system (LNG-IUS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bladder perforation | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hormonal symptoms | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ritva Hurskainen | Helsinki University | +23845872267 | ritva.hurskainen@hus.fi |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| OTHER |
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| Hysterectomy | Procedure | operation |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Hysterectomy (abdominal,laparoscopical or vaginal)
|
|
| Primary | Costs | Not Posted | May 2010 | Number | baseline, 6 and 12 months, 5 and 10 years |
| Secondary | Depression | Not Posted | May 2010 | baseline, 6 and 12 months, 5 and 10 years |
| 0 |
| 80 |
| EG001 | Hysterectomy | Hysterectomy (abdominal,laparoscopical or vaginal) | 5 | 25 |
| peritonitis | Surgical and medical procedures | Systematic Assessment |
|
| vesicovaginal fistula | Surgical and medical procedures | Systematic Assessment |
|
| menstrual bleeding problems | Surgical and medical procedures | Systematic Assessment |
|
| wund infection | Surgical and medical procedures | Systematic Assessment |
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| perioperative bleeding | Surgical and medical procedures | Systematic Assessment |
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| postoperative bleeding | Surgical and medical procedures | Systematic Assessment |
|
| urinary retention | Surgical and medical procedures | Systematic Assessment |
|
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |