Clinical trial NCT03027648: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenomyosis
Keywords: levonorgestrel-releasing intrauterine system
adenomyosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
timeFrame: 5 years after placement of levonorgestrel-releasing intrauterine system
Secondary outcomes:
measure: unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system
timeFrame: 5 years after placement of levonorgestrel-releasing intrauterine system
measure: spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system
timeFrame: 5 years after placement of levonorgestrel-releasing intrauterine system
measure: improvement of symptoms of adenomyosis assessed by verbal rating scales for pain
timeFrame: 5 years after placement of levonorgestrel-releasing intrauterine system
measure: improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea
timeFrame: 5 years after placement of levonorgestrel-releasing intrauterine system
measure: improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea
timeFrame: 5 years after placement of levonorgestrel-releasing intrauterine system
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Leng Jinghua, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.