NCT00966264

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

Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: Female
• Age: 35 Years – 49 Years
• Healthy volunteers: Accepted

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).

Conditions

• Menorrhagia

Interventions

Type	Name	Description
DRUG	LNG-IUS	LNG-IUS releasing 25 microg of levonorgestrel
PROCEDURE	Hysterectomy	operation

Timeline

• Start date: 1994-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2009-08-26
• Last updated: 2009-09-02
• Results posted: 2009-08-26