Status:
COMPLETED
Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
University of Eastern Finland
University of Oulu
Conditions:
Menorrhagia
Eligibility:
FEMALE
35-49 years
Phase:
PHASE3
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- heavy menstrual bleeding
- 35-49 years
- were menstruating
- had completed their family size
- were eligible for both treatments
Exclusion
- 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
Key Trial Info
Start Date :
October 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00966264
Start Date
October 1 1994
End Date
October 1 2008
Last Update
September 2 2009
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