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

Phase 3

Completed

• Conditions: Menorrhagia
• Interventions: Drug: LNG-IUS; Procedure: Hysterectomy

• Registration Number: NCT00966264
• Lead Sponsor: University of Helsinki

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 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

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).

Study Timeline

• Study Start: 1994-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2009-01-20
• Results First Submitted: 2009-01-20
• Study First Submitted QC: 2009-07-24
• Results First Submitted QC: 2009-07-24
• Status Verified: 2009-08
• Study First Posted: 2009-08-26
• Results First Posted: 2009-08-26
• Last Update Submitted: 2009-08-26
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
LNG-IUS	LNG-IUS	Levonorgestrel releasing intrauterine system
LNG-IUS	Hysterectomy	Levonorgestrel releasing intrauterine system
Hysterectomy	LNG-IUS	Hysterectomy
Hysterectomy	Hysterectomy	Hysterectomy

Primary Outcome Measures

Name	Time	Method
HRQoL (Health Related Quality of Life)	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	baseline, 6 and 12 months, 5 and 10 years

Secondary Outcome Measures

Name	Time	Method
Depression	baseline, 6 and 12 months, 5 and 10 years