A clinical study to evaluate efficacy of a copper containing intrauterine device (Coated Copper- T) in reducing bleeding side effects.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/01/006535

Enrollment

200

Registered

2016-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Coated Copper T: Copper Containing intra Uterine Device coated with an FDA approved biodegradable polymer which will degrade in the body to original monomers lactic acid and glycolic ac

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
To assess heavy menstrual bleeding between two groups using coated Copper T and conventional Copper T device.Timepoint: 12 months	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr G Rajmohan

HLL Lifecare Limited

abi@lifecarehll.com9447368939

Outcome results