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