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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Helsinki University; University of Helsinki
• Collaborators: Tampere University; University of Eastern Finland; University of Oulu; University of Tampere; University of Turku
• Treatments: Levonorgestrel

Criteria

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