Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 404 for:    LEVONORGESTREL

Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03027648
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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


Condition or disease Intervention/treatment Phase
Adenomyosis Procedure: Placement of levonorgestrel-releasing intrauterine system Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
Study Start Date : December 2006
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients with LNG-IUS
Placement of levonorgestrel-releasing intrauterine system
Procedure: Placement of levonorgestrel-releasing intrauterine system
All the patients accepted treatment of levonorgestrel-releasing intrauterine system




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027648


Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Leng Jinghua, MD Peking Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lei Li, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03027648     History of Changes
Other Study ID Numbers: PUMCH-OBGYN-2014
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with researchers via online database
Keywords provided by Lei Li, Peking Union Medical College Hospital:
levonorgestrel-releasing intrauterine system
adenomyosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenomyosis
Uterine Diseases
Genital Diseases, Female
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral