LNG-IUS for Treatment of Dysmenorrhea
Condition: Adenomyosis
MeSH terms: Adenomyosis; Dysmenorrhea
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): LNG-IUS; Combined oral contraceptives
Intervention type(s): Device; Drug
Intervention description(s): The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them; Group II: will recite combined oral contraceptives for 6 months
Other intervention name(s): Mirena; Gynera
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adenomyosis; Intrauterine levonorgestrel; Dysmenorrhea; Oral contraceptives; Uterus