Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
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About
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
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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