LNG-IUS for Treatment of Dysmenorrhea

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Brief Title

LNG-IUS for Treatment of Dysmenorrhea

Official Title

Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: a Randomized Controlled Trial

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Adenomyosis

Intervention

LNG-IUS

Study Arms / Comparison Groups

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

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

62

Start Date

April 2012

Completion Date

April 2015

Primary Completion Date

April 2013

Eligibility Criteria

        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
      

Gender

Female

Ages

20 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Administrative Informations


NCT ID

NCT01601366

Organization ID

LNG-IUS-dysmenorrhea

Secondary IDs

AUM001206

Responsible Party

Sponsor-Investigator

Study Sponsor

Omar Mamdouh Shaaban


Study Sponsor

, , 


Verification Date

November 2017