A clinical study to evaluate efficacy of a copper containing intrauterine device (Coated Copper- T) in reducing bleeding side effects.
- Registration Number
- CTRI/2016/01/006535
- Lead Sponsor
- HLL Lifecare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 176
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess heavy menstrual bleeding between two groups using coated Copper T and conventional Copper T device.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method IUD removals are detected during the scheduled visits. IUD must be removed from the subject at the end of the study.Timepoint: 12 months;Pain and comfort level will be assessed by the Quality of Life questionnaire.Timepoint: 12 months;patient reports IUD expulsion, these events are detected during the scheduled visitsTimepoint: 12 months;positive urine pregnancy test at any time within 12 months of the studyTimepoint: 12 months