Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

January 19, 2017 updated by: Lei Li, Peking Union Medical College Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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
Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system
5 years after placement of levonorgestrel-releasing intrauterine system
spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system
Time Frame: 5 years after placement 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
Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system
verbal rating scales for pain
5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea
Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system
hemoglobin for menorrhea
5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea
Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system
visual analogue scale for pain
5 years after placement of levonorgestrel-releasing intrauterine system

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Leng Jinghua, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 15, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-OBGYN-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared with researchers via online database

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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