Phase 3
N=236
Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Menorrhagia
Bottom Line
View on ClinicalTrials.gov: NCT00966264 ↗Enrolled (actual)
236
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: HRQoL (Health Related Quality of Life) — 0.08; 0.10 points on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LNG-IUS (Drug); Hysterectomy (Procedure)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- University of Helsinki
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HRQoL (Health Related Quality of Life) |
0.08; 0.10 | — |
| PRIMARY Costs |
— | — |
| SECONDARY Depression |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00966264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.