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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- To assess heavy menstrual bleeding between two groups using coated Copper T and conventional Copper T device.
研究概览
简要总结
Summary
Bleeding is one of the mostcommon complications in IUD users. Copper T Intra uterine devices (IUD) represent an importantcontraceptive option for a very large number of women, about 160 millionworldwide. We have clinically evaluated the efficacy of Coated Copper T (CCT) inreducing the bleeding side effects as compared with Ordinary Copper T 380A(OCT).
This multicentre,randomized, single-blind, parallel-arm clinical trial was performed on 200women in multiple sites from June 2016 to May 2018, in India. Participants wereallocated into two equal groups for receiving CCT or OCT IUDs in simplerandomized method (1:1). Data were collected by demographic questionnaires andpictorial blood assessment chart (PBAC) and quality of life assessments afterIUD insertion.
In this trial, between July 23 2016 and March 20 2017, 200eligible participants were randomly assigned, of whom 100 patients wereenrolled in CCT group and 100 were enrolled in OCT group. The Mean scorebleeding in the first three months to 12 months after IUD insertion in IUD CCTusers was significantly (p<0·05) lower than IUD Copper T 380A group. Thenumber of times a participant reported either moderate or severe pain was morein the OCT group as compared to the CCT group. No pregnancies or expulsion ofIUD was reported in either of the study groups.
CCT has shown promise inour study in decreasing the menstrual blood loss and pain significantly when compared to the group using conventional OCT device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age between 21 and 35 years (inclusive),
- •In good general health
- •With proven fertility and requesting contraception(Nulliparous women requesting contraception can also be included)
- •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 “Pap†smear 10.Untreated acute cervicitis until infection is controlled 11.Diagnosed Wilson‟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.
结局指标
主要结局
To assess heavy menstrual bleeding between two groups using coated Copper T and conventional Copper T device.
时间窗: 12 months
次要结局
- Pain and comfort level will be assessed by the Quality of Life questionnaire.(12 months)
- positive urine pregnancy test at any time within 12 months of the study(12 months)
- patient reports IUD expulsion, these events are detected during the scheduled visits(12 months)
- IUD removals are detected during the scheduled visits. IUD must be removed from the subject at the end of the study.(12 months)