Levonorgestrel Intrauterine System and Adenomyosis

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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?

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.
    



Study Type

Interventional


Primary Outcome

number of bleeding days per months


Condition

Adenomyosis

Intervention

Levonorgestrel intrauterine system

Study Arms / Comparison Groups

 Levonorgestrel intrauterine system
Description:  

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

Device

Estimated Enrollment

100

Start Date

June 2015

Completion Date

August 2016

Primary Completion Date

July 2016

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
      

Gender

Female

Ages

20 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT03104309

Organization ID

LNG_ADENO


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

, , 


Verification Date

April 2017