Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Not Applicable

Completed

• Conditions: Adenomyosis
• Interventions: Procedure: Placement of levonorgestrel-releasing intrauterine system

• Registration Number: NCT03027648
• Lead Sponsor: Peking Union Medical College Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2014-12
• Status Verified: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with LNG-IUS	Placement of levonorgestrel-releasing intrauterine system	Placement of levonorgestrel-releasing intrauterine system

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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