MedTrace Logo

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

NCT00966264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2009-09-02

Study results available
· View outcomes & findings →

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.

Conditions

  • Menorrhagia

Interventions

DRUG

LNG-IUS

LNG-IUS releasing 25 microg of levonorgestrel

PROCEDURE

Hysterectomy

operation

Sponsors & Collaborators

  • University of Eastern Finland

    collaborator OTHER

  • University of Oulu

    collaborator OTHER

  • Tampere University

    collaborator OTHER

  • University of Turku

    collaborator OTHER

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Ritva S Hurskainen, MD, PhD · Helsinki University Central Hospital

  • Jorma Paavonen, prof · University of Helsinki

  • Juha Teperi, prof · National Istitute For Health and Welfare, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1994-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00966264 on ClinicalTrials.gov