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Levonorgestrel Intrauterine System and Adenomyosis

Primary Purpose

Adenomyosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levonorgestrel intrauterine system
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • adenomyosis
  • request for contraception
  • resident in the nearby vicinity to make the follow-up easy and feasible

Exclusion Criteria:

  • history of ectopic pregnancy
  • puerperal sepsis
  • pelvic inflammatory disease
  • evidence of coagulopathy
  • abnormalities of the uterine cavity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Levonorgestrel intrauterine system

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of bleeding days per months
    The degree of pain perception by visual analogue scale

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2017
    Last Updated
    April 13, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03104309
    Brief Title
    Levonorgestrel Intrauterine System and Adenomyosis
    Official Title
    Can the Effect of Levonorgestrel Intrauterine System for Treatment of Adenomyosis be Predicted at Baseline Visit?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It is a common condition in women aged 40-50 years and is considered an important cause of dysmenorrhea and menorrhagia in around 65 % of cases. Until past few years; hysterectomy was the suggested definitive treatment, however; this may not be acceptable to women not willing to loss their fertility. Many treatment lines were studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol, combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these line of treatment are not commonly used because high incidence of side effects and relatively high cost of some of them. The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to 12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to decidualization and atrophy of the adenomyosis . In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to remove it and start a new medical or surgical option for treatment. However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well available. Only one report states that a large uterine volume could be a factor associated with LNG-IUS treatment discontinuation in adenomyotic patient. For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which should be addressed. The present study examines the hypothesis that patient's data reported at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help the prediction of the responsiveness for this important line of treatment at 6 months follow up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenomyosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levonorgestrel intrauterine system
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Levonorgestrel intrauterine system
    Intervention Description
    Levonorgestrel intrauterine system for adenomyosis
    Primary Outcome Measure Information:
    Title
    number of bleeding days per months
    Time Frame
    6 months
    Title
    The degree of pain perception by visual analogue scale
    Time Frame
    6months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adenomyosis request for contraception resident in the nearby vicinity to make the follow-up easy and feasible Exclusion Criteria: history of ectopic pregnancy puerperal sepsis pelvic inflammatory disease evidence of coagulopathy abnormalities of the uterine cavity

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Levonorgestrel Intrauterine System and Adenomyosis

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