Clinical Trial: Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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


Detailed Summary:
Sponsor: Peking Union Medical College Hospital

Current 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 [ Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system ]

visual analogue scale for pain


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system [ Time Frame: 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 ]
  • 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
  • improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea [ Time Frame: 5 years after placement of levonorgestrel-releasing intrauterine system ]
    hemoglobin for menorrhea
  • 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


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: January 15, 2017
Date Started: December 2006
Date Completion:
Last Updated: January 19, 2017
Last Verified: January 2017