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

Interventional


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

Condition

Adenomyosis

Intervention

Placement of levonorgestrel-releasing intrauterine system

Study Arms / Comparison Groups

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

Publications

* 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

Procedure

Estimated Enrollment

1100

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
      

Gender

Female

Ages

20 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Leng Jinghua, MD, , 



Administrative Informations


NCT ID

NCT03027648

Organization ID

PUMCH-OBGYN-2014


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