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临床试验/CTRI/2016/01/006535
CTRI/2016/01/006535已完成2 期

A Randomized, single blind, multi-center, parallel-arm, pilot scale study to ascertain the efficacy of coated Copper T in reducing bleeding side effects as Compared with Copper T 380 A for a maximum of 1 year

HLL Lifecare Limited0 个研究点目标入组 176 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
176

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Age between 21 and 35 years (inclusive),
  • 2. In good general health
  • 3. With proven fertility and requesting
  • contraception(Nulliparous women requesting
  • contraception can also be included)
  • 4. Has regular menstrual cycles (length of cycle
  • 21-35 days) (i.e., endogenous Cyclicity without
  • hormonal contraceptive use)

排除标准

  • 1.Known or suspected pregnancy
  • 2.Breast feeding females
  • 3.Patients using anti-coagulants
  • 4.History of ectopic pregnancies
  • 5.Any genital infection (until successfully treated)
  • 6.Abnormal uterine bleeding of any origin including bleeding due to unknown causes
  • 7.Abnormalities of the uterus resulting in distortion of the uterine cavity
  • 8.Postpartum endometritis or infected abortion and MTP in the past < 3 months
  • 9.Known or suspected uterine or cervical malignancy, including unresolved, abnormal â??Papâ?? smear
  • 10.Untreated acute cervicitis until infection is controlled
  • 11.Diagnosed Wilsonâ??s disease
  • 12.Known allergy to copper
  • 13.Conditions associated with increased susceptibility to infection. Such conditions include, but are not limited to leukemia, diabetes acquired immune deficiency syndrome (AIDS), and those requiring chronic corticosteroid therapies
  • 14.Genital actinomycosis
  • 15.A previously inserted IUD that has not been removed

研究者

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