Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Study Overview
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Brief Summary
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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

Official Title
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Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Conditions
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Adenomyosis

Intervention / Treatment
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* Procedure: Placement of levonorgestrel-releasing intrauterine system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with LNG-IUS<br>Placement of levonorgestrel-releasing intrauterine system | Procedure: Placement of levonorgestrel-releasing intrauterine system<br>* All the patients accepted treatment of levonorgestrel-releasing intrauterine system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 years after placement of levonorgestrel-releasing intrauterine system | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | verbal rating scales for pain | 5 years after placement of levonorgestrel-releasing intrauterine system | 
| improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea | hemoglobin for menorrhea | 5 years after placement of levonorgestrel-releasing intrauterine system | 
| improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea | visual analogue scale for pain | 5 years after placement of levonorgestrel-releasing intrauterine system | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levonorgestrel-releasing intrauterine system, adenomyosis