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临床试验/NCT01601366
NCT01601366已完成2 期

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

Omar Mamdouh Shaaban0 个研究点目标入组 62 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
62
主要终点
Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

LNG-IUS (Mirena)

Experimental

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

干预措施: LNG-IUS (Device)

Combined oral contraceptives

Active Comparator

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

干预措施: Combined oral contraceptives (Drug)

结局指标

主要结局

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

时间窗: 6 month

次要结局

  • Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months(6 month)

研究者

发起方
Omar Mamdouh Shaaban
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Omar Mamdouh Shaaban

Dr.

Assiut University

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