Skip to main content
OpenTrials
Completed

NCT Number: NCT03027648

Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of levonorgestrel-releasing intrauterine system

Procedure

All the patients accepted treatment of levonorgestrel-releasing intrauterine system

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system

  2. spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system

    Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system

  3. 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

  4. improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea

    Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system

    hemoglobin for menorrhea

  5. 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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Important dates

Study start
2006
Primary completion
2014
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.