NCT03027648

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

8 years

First QC Date

January 15, 2017

Last Update Submit

January 19, 2017

Conditions

Adenomyosis

Keywords

levonorgestrel-releasing intrauterine systemadenomyosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea

    5 years after placement of levonorgestrel-releasing intrauterine system

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

    5 years after placement of levonorgestrel-releasing intrauterine system

Study Arms (1)

patients with LNG-IUS

OTHER

Placement of levonorgestrel-releasing intrauterine system

Procedure: Placement of levonorgestrel-releasing intrauterine system

Interventions

Placement of levonorgestrel-releasing intrauterine systemPROCEDURE

All the patients accepted treatment of levonorgestrel-releasing intrauterine system

patients with LNG-IUS

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Desire for pregnancy or lactation
  • With diagnosis of malignancies or precancerous lesions
  • Acceptance of laparotomy
  • Contraindication of placing levonorgestrel-releasing intrauterine system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li L, Leng J, Jia S, Lang J. Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system. Int J Gynaecol Obstet. 2019 Sep;146(3):357-363. doi: 10.1002/ijgo.12887. Epub 2019 Jun 27.

    PMID: 31194884DERIVED

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Leng Jinghua, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2017

First Posted

January 23, 2017

Study Start

December 1, 2006

Primary Completion

December 1, 2014

Study Completion

January 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

IPD will be shared with researchers via online database