Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Peking Union Medical College Hospital1,100 enrolled

Overview

Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis. Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects. Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea Second outcome measures: carrying status of IUS

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,100

Conditions

Adenomyosis

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with regular menses * Adenomyosis diagnosed via transvaginal ultrasound * With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores \>100) * Duration of placement \> 12 months * Size of uterus by physical examination less than uterus of 12-week pregnancy Exclusion Criteria: * Desire for pregnancy or lactation * With diagnosis of malignancies or precancerous lesions * Acceptance of laparotomy * Contraindication of placing levonorgestrel-releasing intrauterine system

Outcomes

Primary Outcomes

improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system

visual analogue scale for pain