CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 236 enrolled
Drug / intervention
LNG-IUS +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00966264
NCT00966264Phase 3Completed
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Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

University of Helsinki·interventional·Posted Aug 26, 2009·Updated Sep 2, 2009

In Brief

A Phase 3 clinical trial evaluating LNG-IUS and Hysterectomy for Menorrhagia. Completed, enrolled 236 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia
Countries--
CollaboratorsUniversity of Eastern Finland, University of Oulu, Tampere University, University of Turku

Timeline

Phase 3CompletedFinished
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First PostedAug 26, 2009
Enrollment StartOct 1, 1994
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 14 yearsPosted 16.8 years ago

Interventions

LNG-IUSdrug

LNG-IUS releasing 25 microg of levonorgestrel

Hysterectomyprocedure

operation