Adenomyosis
Conditions
Keywords
levonorgestrel-releasing intrauterine system, adenomyosis
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
Interventions
PROCEDUREPlacement of levonorgestrel-releasing intrauterine system
All the patients accepted treatment of levonorgestrel-releasing intrauterine system
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system | 5 years after placement of levonorgestrel-releasing intrauterine system | visual analogue scale for pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | verbal rating scales for pain |
| improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea | 5 years after placement of levonorgestrel-releasing intrauterine system | hemoglobin for menorrhea |
| improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea | 5 years after placement of levonorgestrel-releasing intrauterine system | visual analogue scale for pain |
Outcome results
None listed