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