Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

checkorphan
Learn more about:
Adenomyosis
Related Clinical Trial
Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis The Effect of Adenomoyosis on Pregnancy Outcomes Observational Study of Patients Suffering From Endometriosis and Adenomyosis Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis Quality of Life After Hysterectomy (AdenoQOL) Low Molecular Weight Heparin on the Adenomyosis Patients’IVF-ET Outcome Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI Clinical and Molecular Study of Endometriosis and Adenomyosis Surgical Success After Laparoscopic vs Abdominal Hysterectomy Electronic Catheter Stethoscope Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Uterine Artery Embolization for Symptomatic Fibroids Oxytocin in MRI-HIFU To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy Effect of Addition of Steroids on Duration of Analgesia Paracervical Block in Laparoscopic Hysterectomy Use of Dexamethasone in Uterine Artery Embolization Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) Dienogest for Treatment of Adenomyotic Uteri Health-Related QoL Among Women Receiving Hysterectomy in NTUH Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis Adenomyosis and Ulipristal Acetate Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis LNG-IUS for Treatment of Dysmenorrhea Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Adenomyosis: Genomic Mechanisms and Biological Response What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis A Prospective Study of Diagnostic Accuracy of Ultrasound Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis A Multi-omics Study of Adenomyosis Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis Levonorgestrel Intrauterine System and Adenomyosis Validation of the Adenomyosis Calculator Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Norwegian Adenomyosis Study III: Peristalsis Histopathological Diagnosis of Adenomyosis Norwegian Adenomyosis Study I Vaginal Bromocriptine for Treatment of Adenomyosis Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

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