Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

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Brief Title

Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Official Title

Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P

Brief Summary

      Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of
      the uterus. It affects about 15-20% of the female population.

      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation
      (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment
      levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues,
      Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study
      is to compare the efficacy and usefulness of association of oral contraceptive pill and
      LNG-IUS or LNG-IUS alone
    



Study Type

Interventional


Primary Outcome

Change of Pelvic pain as measured by visual analogue scale

Secondary Outcome

 Change of Pelvic pain as measured by visual analogue scale

Condition

Adenomyosis

Intervention

LNG-IUS 13,5 mg Levonorgestrel

Study Arms / Comparison Groups

 LNG-IUS
Description:  LNG-IUS 13,5 mg di Levonorgestrel

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

Drug

Estimated Enrollment

50

Start Date

June 1, 2021

Completion Date

June 1, 2022

Primary Completion Date

December 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Women affected by adenomyosis with pelvic pain > 4;

          -  Negative Pap Smear test

        Exclusion Criteria:

          -  Pregnancy or research of pregnancy

          -  Refusal or inability to sign informed consent

          -  Severe underlying comorbidities (hepatic, oncological)

          -  Pelvic inflammatory disease

          -  Other cervical or uterine pathologies

          -  Deep venous thromboembolism

          -  Hormonal therapy contraindications

          -  Smoke
      

Gender

Female

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 



Administrative Informations


NCT ID

NCT02556411

Organization ID

ADENOMYOSIS


Responsible Party

Principal Investigator

Study Sponsor

University of Cagliari


Study Sponsor

, , 


Verification Date

February 2021