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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-10-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hysterectomy - A Regional Intervention Study

NCT05255120

Benign Hysterectomy Postoperative Recovery Preoperative Planning

COMPLETED NA

Quality of Life After Hysterectomy (AdenoQOL)

NCT04791033

Adenomyosis Quality of Life

ACTIVE_NOT_RECRUITING

Effect of Salpingectomy During Conservative Hysterectomy

NCT01628432

Genital Diseases, Female Hysterotomy; Affecting Fetus Leiomyomata Uteri +4 more

COMPLETED NA

Impact of Incomplete Endometrial Ablation

NCT06122363

Heavy Menstrual Bleeding

ACTIVE_NOT_RECRUITING

Same Day Discharge vs. Overnight Stay After Hysterectomy

NCT03627234

Satisfaction Safety Issues Quality of Life

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menorrhagia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LNG-IUS

Levonorgestrel releasing intrauterine system

Group Type ACTIVE_COMPARATOR

LNG-IUS

Intervention Type DRUG

LNG-IUS releasing 25 microg of levonorgestrel

Hysterectomy

Intervention Type PROCEDURE

operation

Hysterectomy

Group Type OTHER

LNG-IUS

Intervention Type DRUG

LNG-IUS releasing 25 microg of levonorgestrel

Hysterectomy

Intervention Type PROCEDURE

operation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LNG-IUS

LNG-IUS releasing 25 microg of levonorgestrel

Intervention Type DRUG

Hysterectomy

operation

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mirena Removal of uterus by laparoscopy, vaginally or abdominally

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes