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
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Administrative Informations
NCT ID
NCT02556411
Organization ID
ADENOMYOSIS
Responsible Party
Principal Investigator
Study Sponsor
University of Cagliari
Study Sponsor
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Verification Date
February 2021