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Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Primary Purpose

Adenomyosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Placement of levonorgestrel-releasing intrauterine system

About this trial

This is an interventional treatment trial for Adenomyosis focused on measuring levonorgestrel-releasing intrauterine system, adenomyosis

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with LNG-IUS

Arm Description

Placement of levonorgestrel-releasing intrauterine system

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system

spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system

improvement of symptoms of adenomyosis assessed by verbal rating scales for pain

verbal rating scales for pain

improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea

hemoglobin for menorrhea

improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea

visual analogue scale for pain

Full Information

NCT ID

NCT03027648

First Posted

January 15, 2017

Last Updated

January 19, 2017

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03027648

Brief Title

Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenomyosis

Keywords

levonorgestrel-releasing intrauterine system, adenomyosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patients with LNG-IUS

Arm Type

Other

Arm Description

Placement of levonorgestrel-releasing intrauterine system

Intervention Type

Procedure

Intervention Name(s)

Placement of levonorgestrel-releasing intrauterine system

Intervention Description

All the patients accepted treatment of levonorgestrel-releasing intrauterine system

Primary Outcome Measure Information:

Title

improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system

Description

visual analogue scale for pain

Time Frame