Clinical trial NCT00966264: Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Official title: Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menorrhagia
Keywords: randomized controlled trial
menorrhagia
LNG-IUS
hysterectomy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: University of Oulu
name: Tampere University
name: University of Turku
First posted: 2009-08-26
Enrollment: 236
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: HRQoL (Health Related Quality of Life)
timeFrame: baseline and 5 years
measure: Costs
timeFrame: baseline, 6 and 12 months, 5 and 10 years
Secondary outcomes:
measure: Depression
timeFrame: baseline, 6 and 12 months, 5 and 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Ritva S Hurskainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Jorma Paavonen, prof
role: STUDY_DIRECTOR
affiliation: National Istitute For Health and Welfare, Finland
name: Juha Teperi, prof
role: STUDY_CHAIR
References: