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

University of Helsinki

Status and phase: Completed; Phase 3

Conditions: Menorrhagia

Treatments: Procedure: Hysterectomy; Drug: LNG-IUS

Study type: Interventional

Funder types: Other

Identifiers

NCT00966264

Finnish Academy-project 29168

Details and patient eligibility

About

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.

Full 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).

Enrollment: 236 patients

Sex: Female

Ages: 35 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

236 participants in 2 patient groups

LNG-IUS

Active Comparator group

Description:

Levonorgestrel releasing intrauterine system

Treatment:

Procedure: Hysterectomy

Drug: LNG-IUS

Hysterectomy

Other group

Description:

Hysterectomy

Treatment:

Procedure: Hysterectomy

Drug: LNG-IUS