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

Information source: Helsinki University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menorrhagia

Intervention: LNG-IUS (Drug); Hysterectomy (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Helsinki University

Official(s) and/or principal investigator(s):
Ritva S Hurskainen, MD, PhD, Principal Investigator, Affiliation: Helsinki University Hospital
Jorma Paavonen, prof, Study Director, Affiliation: Helsinki University
Juha Teperi, prof, Study Chair, Affiliation: National Istitute For Health and Welfare, Finland

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.

Clinical Details

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

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

Primary outcome:

HRQoL (Health Related Quality of Life)

Costs

Secondary outcome: Depression

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

Minimum age: 35 Years. Maximum age: 49 Years. Gender(s): Female.

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

Locations and Contacts

Additional Information

Starting date: October 1994
Last updated: August 26, 2009

Page last updated: August 23, 2015

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