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LNG-IUS for Treatment of Dysmenorrhea (LNGIUSAD)

Primary Purpose

Adenomyosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LNG-IUS
Combined oral contraceptives
Sponsored by
Omar Mamdouh Shaaban
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis focused on measuring Adenomyosis, Intrauterine levonorgestrel, Dysmenorrhea, Oral contraceptives, Uterus

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis.
  2. Planning for birth spacing for at least 2 years.
  3. Patient aged between 20-45 years old.
  4. Ultrasonographic and Doppler examination suggestive of adenomyosis.
  5. Living in a nearby area to make follow-up reasonably possible.

Exclusion Criteria:

  1. Pregnancy
  2. Evidence of defective coagulation.
  3. History or evidence of malignancy.
  4. Hyperplasia in the endometrial biopsy.
  5. Incidental adnexal abnormality on ultrasound.
  6. Contraindications to COCs.
  7. Absolute contraindication of LNG-IUS insertion.
  8. Previous endometrial ablation or resection
  9. Uninvestigated postcoital bleeding
  10. Untreated abnormal cervical cytology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LNG-IUS (Mirena)

    Combined oral contraceptives

    Arm Description

    Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them

    Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months

    Outcomes

    Primary Outcome Measures

    Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.

    Secondary Outcome Measures

    Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months

    Full Information

    First Posted
    May 15, 2012
    Last Updated
    November 20, 2017
    Sponsor
    Omar Mamdouh Shaaban
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01601366
    Brief Title
    LNG-IUS for Treatment of Dysmenorrhea
    Acronym
    LNGIUSAD
    Official Title
    Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (Actual)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Omar Mamdouh Shaaban

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the myometrium are associated with surrounding myometrial hypertrophy. The finding classically associated with adenomyosis is excessive uterine bleeding accompanied by worsening dysmenorrhea. The advent of endovaginal US has substantially improved the ability to diagnose adenomyosis. Different US features of adenomyosis have been reported, including uterine enlargement not explainable by the presence of leiomyomas, asymmetric thickening of the anterior or posterior myometrial wall, lack of contour abnormality or mass effect, heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of varying sizes, and increased echotexture of the myometrium. Transvaginal power Doppler application is useful in studying the vascular tree of adenomyosis and can aid clinicians in planning the most appropriate therapeutic strategy. The differential diagnosis using power Doppler sonography is based on vascular characteristics. Adenomyosis is characterized by a preserved vascular texture supply that results in dilated spiral arteries running perpendicular toward the myometrium into the endometrial surface. Leiomyomata exhibits a vascular tree that typically circumscribes the solid mass. 2D transvaginal power Doppler angiography should be used to improve diagnostic sensitivity and facilitate appropriate therapeutic intervention. The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe for contraception since 1990. Because of the suppressive effect of levonorgestrel on the endometrium, Mirena has also been proven to be effective for the management of menorrhagia and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many cases of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for the treatment of adenomyosis in Taiwan. The current study is designed to evaluate the best treatment modality for treatment of adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and Doppler indices.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenomyosis
    Keywords
    Adenomyosis, Intrauterine levonorgestrel, Dysmenorrhea, Oral contraceptives, Uterus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LNG-IUS (Mirena)
    Arm Type
    Experimental
    Arm Description
    Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them
    Arm Title
    Combined oral contraceptives
    Arm Type
    Active Comparator
    Arm Description
    Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months
    Intervention Type
    Device
    Intervention Name(s)
    LNG-IUS
    Other Intervention Name(s)
    Mirena
    Intervention Description
    The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them
    Intervention Type
    Drug
    Intervention Name(s)
    Combined oral contraceptives
    Other Intervention Name(s)
    Gynera
    Intervention Description
    Group II: will recite combined oral contraceptives for 6 months
    Primary Outcome Measure Information:
    Title
    Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months
    Time Frame
    6 month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis. Planning for birth spacing for at least 2 years. Patient aged between 20-45 years old. Ultrasonographic and Doppler examination suggestive of adenomyosis. Living in a nearby area to make follow-up reasonably possible. Exclusion Criteria: Pregnancy Evidence of defective coagulation. History or evidence of malignancy. Hyperplasia in the endometrial biopsy. Incidental adnexal abnormality on ultrasound. Contraindications to COCs. Absolute contraindication of LNG-IUS insertion. Previous endometrial ablation or resection Uninvestigated postcoital bleeding Untreated abnormal cervical cytology

    12. IPD Sharing Statement

    Learn more about this trial

    LNG-IUS for Treatment of Dysmenorrhea

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