Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,100
- Primary Endpoint
- improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- 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
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
Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system
visual analogue scale for pain
Secondary Outcomes
- unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system(5 years after placement of levonorgestrel-releasing intrauterine system)
- spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system(5 years after placement of levonorgestrel-releasing intrauterine system)
- improvement of symptoms of adenomyosis assessed by verbal rating scales for pain(5 years after placement of levonorgestrel-releasing intrauterine system)
- improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea(5 years after placement of levonorgestrel-releasing intrauterine system)
- improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea(5 years after placement of levonorgestrel-releasing intrauterine system)
Investigators
Lei Li
Associate Professor
Peking Union Medical College Hospital