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Trial record 1 of 2 for:    implanon | endometriosis
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Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis

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ClinicalTrials.gov Identifier: NCT02480647
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE June 17, 2015
First Posted Date  ICMJE June 24, 2015
Last Update Posted Date August 14, 2017
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Pelvic pain. Pain intensity measure: Self reported pain intensity daily. each item scored 0-10. [ Time Frame: 6 months ]
Self reported pain intensity in the morning, afternoon, evening and winch activity over. Each item is scored 0-10. ( 0=no pain; 10= pain as bad as can be.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
  • Uterine bleeding [ Time Frame: 6 months ]
    Self reported uterine bleeding in the morning, evening and which activity over. Each item is noted in menstrual calendar. ( 0=no bleeding; 1= spotting; 2- light and 3= intense, noted by the participant in menstrual calendar daily
  • Cancer antigen 125 [ Time Frame: Baseline and after 180 days ]
    Ca 125 will be evaluated at baseline and at last follow-up ( +/- 180 days).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis
Official Title  ICMJE Randomized Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Pelvic Pain Control in Women With Endometriosis
Brief Summary

Randomized clinical trial the use of levonorgestrel releasing intrauterine system.

Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.

Detailed Description

Randomized clinical trial the use of levonorgestrel releasing intrauterine system.

Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine system (LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the control of chronic pelvic pain and / or dysmenorrhea in women with endometriosis.

Methods: Will be assessed 103 women, aged 18-45 years, diagnosis of endometriosis confirmed by laparoscopy or laparotomy that presents chronic pelvic pain and / or dysmenorrhea. The study will be experimental, randomized , (5' women will be allocated to the LNG-IUS and 52 women will use the implant subdermal ENG). Women will be invited to participate in the study on the day and having the Family Planning Clinic with pelvic pain complaints and / or dysmenorrhea with a confirmed diagnosis of endometriosis in search of inserting a LNG-IUS. That day will be invited to be allocated by lottery (through a system of computer generated randomization; with opaque and sealed envelopes), the group that will use LNG-IUS or subdermal implant ENG. At the inclusion in the study will be held the insertion of the LNG-IUS or ENG implant and on this day the pain will be evaluated by visual analogue scale (VAS) of pain and applied the evaluation questionnaire of endometriosis. It will be a calendar to record delivered daily bleeding and EVA for daily assessment of pain. Women will return each 30 days (± 3 days) where the pain of registration will be evaluated by EVA and will be collected the bleeding and delivered a new calendar for the next 30 days. The end of the study It is expected to 180 days post-insertion of the LNG-IUS or the implant and, in the latter evaluation, will again be applied questionnaire. Cancer antigen 125 (CA-125), CD23 and endometrial biopsy will be evaluated at baseline and at last follow-up ( +/- 180 days).

Inclusion criteria:

  • Women aged 18 to 45
  • Absence of pregnancy
  • Patients with chronic pelvic pain and / or dysmenorrhea with pain scores ≥ 4 on EVA pain and surgical and histopathological diagnosis of endometriosis in 14 last three months to two years, according to the current classification of the American Society for Reproductive Medicine and
  • Accept participate and sign the consent form and clarified.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: Levonorgestrel
    20μg/day.
    Other Names:
    • levonorgestrel releasing intrauterine system
    • Mirena
  • Drug: Etonogestrel
    20μg/day.
    Other Name: Implanon
Study Arms  ICMJE
  • Experimental: levonorgestrel & etonogestrel

    Levonorgestrel releasing intrauterine system

    Other names:

    Mirena.

    Intervention: Drug: Levonorgestrel
  • Active Comparator: etonogestrel

    Etonogestrel implant:

    Other name: Implanon Releasing 20μg/day.

    Intervention: Drug: Etonogestrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 18 to 45
  • Absence of pregnancy
  • Patients with chronic pelvic pain and / or dysmenorrhea with pain scores ≥ 4 on EVA pain and surgical and histopathological diagnosis of endometriosis in 14 last three months to two years, according to the current classification of the American Society for Reproductive Medicine and Enzian classification.
  • Accept participate and sign the consent form and clarified

Exclusion criteria:

  • Current wish to get pregnant
  • I just want to use the LNG-IUS as treatment
  • Contraindication to the use of LNG-IUS: Current pelvic inflammatory disease or appellant; infection of the lower genital tract; infected abortion during the last 3 months; purulent cervicitis; uterine or cervical malignancy; bleeding abnormal uterine undiagnosed; congenital uterine anomalies or acquired conditions associated with increased susceptibility to infections; acute liver disease or liver tumors; hypersensitivity to LNG.
  • Contraindications to the use of ENG implants: pregnancy or suspected pregnancy;
  • Active venous thromboembolic disorder; presence or history of liver disease serious as liver function values have not returned to normal; progestogen dependent tumors; abnormal bleeding undiagnosed; hypersensitivity to any component of implante.
  • Abusive use of alcohol and / or other illicit drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02480647
Other Study ID Numbers  ICMJE 44827415200005404
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luis Bahamondes, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nelsilene Tavares, MD University of Campinas, Brazil
PRS Account University of Campinas, Brazil
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP