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临床试验/NCT02580344
NCT02580344已完成2 期

Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding

Assiut University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年10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
入组人数
128
试验地点
1
主要终点
Number of bleeding days per month

研究概览

简要总结

The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device.

Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting.

Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen.

The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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 menorrhagia secondary to IUD.
  • Planning for birth spacing for at least 1 year.
  • Patient aged between 20-45 years old.
  • No history of any medical treatment.
  • 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.
  • Untreated abnormal cervical cytology
  • contraindications to ibuprofen

研究组 & 干预措施

Ibuprofen

Other

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Number of bleeding days per month

时间窗: 3 months

by menstrual diary

次要结局

  • Uterine Doppler indices(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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