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

Primary Purpose

Adenomyosis, Chronic Pelvic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LNG-IUS 13,5 mg Levonorgestrel
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    LNG-IUS

    combined oral contraceptive plus LNG-IUS

    Arm Description

    LNG-IUS 13,5 mg di Levonorgestrel

    Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel

    Outcomes

    Primary Outcome Measures

    Change of Pelvic pain as measured by visual analogue scale

    Secondary Outcome Measures

    Change of Pelvic pain as measured by visual analogue scale
    Change of Pelvic pain as measured by visual analogue scale
    Change of Pelvic pain as measured by visual analogue scale
    Quality of sexual life

    Full Information

    First Posted
    September 20, 2015
    Last Updated
    February 3, 2021
    Sponsor
    University of Cagliari
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02556411
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LNG-IUS
    Arm Type
    Active Comparator
    Arm Description
    LNG-IUS 13,5 mg di Levonorgestrel
    Arm Title
    combined oral contraceptive plus LNG-IUS
    Arm Type
    Experimental
    Arm Description
    Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
    Intervention Type
    Drug
    Intervention Name(s)
    LNG-IUS 13,5 mg Levonorgestrel
    Intervention Description
    LNG-IUS
    Intervention Type
    Drug
    Intervention Name(s)
    Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
    Intervention Description
    Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime
    Primary Outcome Measure Information:
    Title
    Change of Pelvic pain as measured by visual analogue scale
    Time Frame
    Change from baseline pelvic pain at 45 days of treatment
    Secondary Outcome Measure Information:
    Title
    Change of Pelvic pain as measured by visual analogue scale
    Time Frame
    Change from baseline pelvic pain at 90 days of treatment
    Title
    Change of Pelvic pain as measured by visual analogue scale
    Time Frame
    Change from baseline pelvic pain at 180 days of treatment
    Title
    Change of Pelvic pain as measured by visual analogue scale
    Time Frame
    Change from baseline pelvic pain at 365 days of treatment
    Title
    Quality of sexual life
    Time Frame
    Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    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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