Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

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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

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

Study Type


Primary Outcome

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

Secondary Outcome

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




Placement of levonorgestrel-releasing intrauterine system

Study Arms / Comparison Groups

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


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2006

Completion Date

January 2017

Primary Completion Date

December 2014

Eligibility Criteria

        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




20 Years - 45 Years

Accepts Healthy Volunteers



Leng Jinghua, MD, , 

Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Peking Union Medical College Hospital

Study Sponsor

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

Verification Date

January 2017