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

Menorrhagia Clinical Trial

— VUOKKO  

Official title:

Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966264
• Other study ID #: Finnish Academy-project 29168
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2009
• Last updated: August 26, 2009
• Start date: October 1994
• Est. completion date: October 2008

Study information

• Verified date: August 2009
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Drug:
• LNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel

Procedure:
• Hysterectomy
operation

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University	University of Eastern Finland, University of Oulu, University of Tampere, University of Turku

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQoL (Health Related Quality of Life)		baseline and 5 years	No
Primary	Costs		baseline, 6 and 12 months, 5 and 10 years	No
Secondary	Depression		baseline, 6 and 12 months, 5 and 10 years	No