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Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis (NCT03027648)

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
  • Procedure: Placement of levonorgestrel-releasing intrauterine system
    All the patients accepted treatment of levonorgestrel-releasing intrauterine system
    Ages eligible for Study
    20 Years to 45 Years
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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
    Status:
    completed
    Type:
    Interventional
    Phase:
    -
    Start:
    30 November, 2006
    Updated:
    18 January, 2017
    Participants:
    1100
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