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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

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 Summary: 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).
Sponsor: Helsinki University

Current Primary Outcome:

  • HRQoL (Health Related Quality of Life) [ Time Frame: baseline and 5 years ]
  • Costs [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Depression [ Time Frame: baseline, 6 and 12 months, 5 and 10 years ]

Original Secondary Outcome: Same as current

Information By: Helsinki University

Dates:
Date Received: January 20, 2009
Date Started: October 1994
Date Completion:
Last Updated: August 26, 2009
Last Verified: August 2009